WO2006076668A1

WO2006076668A1 - Device and method for the display and printing of an analyte concentration in a fluid sample

Info

Publication number: WO2006076668A1
Application number: PCT/US2006/001406
Authority: WO
Inventors: Robert D. Schell
Original assignee: Bayer Healthcare Llc
Priority date: 2005-01-14
Filing date: 2006-01-13
Publication date: 2006-07-20
Also published as: TW200632317A

Abstract

A test device for determining the analyte concentration in a fluid sample. The test device comprises a measuring unit, a processor, a removable memory device, and a user display. The measuring unit is adapted to measure the reaction of a reagent and the analyte to generate a signal indicative of the measured reaction. The processor is electronically coupled to the measuring unit and is adapted to determine the analyte concentration in the sample in response to the signal from the measuring unit. The removable memory device is electronically coupled to the processor for storing the analyte concentration of a current sample concentration and at least one prior sample concentration. The user display is electronically coupled to the processor and automatically displays the concentration of the current sample.

Description

DEVICE AND METHOD FOR THE DISPLAY AND PRINTING OF AN ANALYTE CONCENTRATION IN A FLUID SAMPLE

FIELD OF THE INVENTION

[0001] The present invention relates generally to liquid-sample monitoring devices and, more particularly, to a liquid sample monitoring device with a removable memory adapted to be used to provide a graphical representation of the analyte concentration in a liquid sample to a computer or a printer.

BACKGROUND OF THE INVENTION

[0002] Individuals who have irregular blood glucose concentration levels are often medically required to self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons, including illness, such as diabetes. The purpose of monitoring the blood glucose level is to determine the concentration level and then to take corrective action, based on whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action may have serious adverse effects on the individual.

[0003] Beyond the above-described blood glucose concentration level monitoring, self- testing systems are used for determining the presence or concentration of other analytes in body fluids, such as, for example, cholesterol, alcohol, and hemoglobin in blood, interstitial fluid, or chemical substances in saliva.

[0004] One method of monitoring a person's blood glucose level is with a portable, handheld, blood glucose device. A prior art blood glucose test device 10 is illustrated in FIG. 1. The portable nature of these devices 10 enables users to conveniently test their blood glucose levels wherever the users may be. The test device 10 receives a test sensor 12 for harvesting the blood for analysis. The test sensor 12, one of which is required for each test, contains a reaction area including a reagent for producing a measurable reaction with the glucose indicative of the blood glucose concentration level. The test sensor harvests the blood, either prior to or subsequent to insertion into the testing device, for reaction with the reagent stored within.

[0005] The prior art device 10 contains a switch 14a to activate the device 10 and a display 16 to display the results of the blood glucose analysis. Alternatively, the device 10 is automatically activated upon receipt of the test sensor 12. To check the blood glucose level, a drop of blood is obtained from, for example, a lanced fingertip. The blood is harvested using the test sensor 12. The test sensor 12, which is inserted into the test device 10 is brought into contact with the blood drop. The test sensor 12 moves the blood to the inside thereof via, for example, capillary action. Alternatively, the blood sample is harvested prior to inserting the test sensor 12 into the test device 10. The blood sample now within the test sensor 12 mixes with the reagent causing a reaction between the reagent and the glucose in the blood sample. The test device 10 then measures the reaction to determine the glucose concentration in the blood sample. The results of the test are displayed on the display 16 of the test device 10. Once the results are displayed, the test sensor 12 is discarded. An additional test would require a new test sensor 12. There are several types of test sensors that may be used for the test, such as, electrochemical or optical (e.g., colorimetric) test sensors to measure blood glucose concentration levels.

[0006] Instances exist where a user needs to keep records of a series of past blood glucose readings to more effectively manage treatment options. Some prior art devices have allowed the user to transfer results from the test device to a computer or a printer serially through a cable or through an infrared ("IR") port. However, these devices required the user to obtain software specifically designed to process the data received from the test device into a format that the computer or printer may recognize, or a special printer containing specific software to process data received from the test device was required. An example of such a program is ASCENCIA® WINGLUCOF ACTS® diabetes management software. Therefore, a need exists for a user-friendly device that allows the user to transfer results from the test device to a computer or printer without the need for special processing equipment.

SUMMARY OF THE INVENTION

[0007] According to one embodiment of the present invention, a test device for determining an analyte concentration in a liquid sample comprises a measuring unit, a processor, a removable memory device, and a user display. The measuring device is adapted to measure the reaction of a reagent and the analyte and generates a signal indicative of the measured reaction. The processor is electrically coupled to the measuring unit. The processor is adapted to determine the analyte concentration in the sample in response to receiving the signal indicative of the measured reaction from the measuring unit. The removable memory device is electronically coupled to the processor and stores the analyte concentration. The removable memory device includes storage of a current sample concentration and at least one prior sample concentration. The user display is electronically coupled to the processor. The user display automatically displays the concentration of the current sample.

[0008] According to one process, a hard copy of a plurality of sample test results stored on a test device that has a removable memory device in which a concentration of at least one past sample is stored is obtained. The test device is adapted to receive a test sensor for collecting the sample. The test sensor contains a reagent adapted to produce a reaction indicative of an analyte concentration in the sample. The process comprises measuring the reaction between an analyte in a current sample and the reagent contained in the test sensor. The concentration of the analyte in the current sample is determined. The concentration of the analyte in the current sample is stored in the removable memory device. The removable memory device is removed from the test device. The removable memory device is inserted into a memory device reader. The stored results in the removable memory are read with the memory device reader. The stored results are printed with a printer.

[0009] The above summary of the present invention is not intended to represent each embodiment or every aspect of the present invention. The detailed description and Figures will describe many of the embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a front view of a prior art blood glucose test device.

[0011] FIG. 2 is a front view of a test device for determining an analyte concentration according to one embodiment of the present invention.

[0012] FIG. 3 is a functional block diagram of the test device of FIG. 2.

[0013] FIG. 4 is a functional block diagram of the test device of FIG. 2 according to an alternative embodiment.

[0014] FIG. 5 is a view of one embodiment of a display to be used on the test device of

FIG. 2.

[0015] FIG. 6 is a view of hard copy of the test results generated on the test device of

FIG. 2.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

[0016] Referring now to the drawings, and initially to FIG. 2, a test device 20 for determining a user's analyte concentration level in a fluid sample is shown according to one embodiment of the present invention. While the following discussion describes determining the glucose concentration in blood, it is understood that the present invention may be employed in determining the concentration of other analytes in other types of samples. Analytes that may be measured using the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A_1C, fructose, lactate, or bilirubin. The present invention is not limited, however, to these specific analytes and it is contemplated that other analyte concentrations may be determined. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.

[0017] The test device 20 includes a housing 22, a test sensor 24, a power button 26a, a plurality of optional control buttons 26b-26e, a display panel 28, and an optional indicating mechanism 30. The power button 26a is used to turn the test device 20 on and off. Alternatively, the test device 20 may automatically activate upon receipt of a test sensor 24. Alternatively, an initial activation (e.g., depression) of one of the control buttons 26b-26e activates the test device 20. The display panel 28 displays the test results. The optional indicating mechanism 30 (e.g., an LED) is used to alert the user to an alarm condition, such as an abnormal reading, a glucose reading that is too high or too low, or another problem with the test device 20. In an alternative embodiment, there is no indicating mechanism 30 and the display panel 28 may be used to alert the user to an alarm condition.

[0018] Referring to FIG. 3, the internal components of the test device 20 will be described. The test device 20 includes a measuring unit 32 that receives a fluid collection apparatus or test sensor 34. hi embodiments where optical testing is used, the measuring unit comprises a spectrograph, a photometric measuring unit, or other measuring unit. The test sensor 34 includes a reagent 36 that reacts with a blood sample, creating a measurable reaction indicative of the concentration of glucose in the blood sample. [0019] The type of reagent implemented in the test device 20 depends on the type of measuring used. For example, in colorimetric testing, the reagent reacts with the glucose in a blood sample causing a colorimetric reaction indicative of the glucose concentration level. A photometric measuring unit or other optical device reads the degree of color change. Colorimetric testing is described in detail in commonly-owned U.S. Patent Nos. 6,181,417 (entitled "Photometric Readhead With Light Shaping Plate"), 5,518,689 (entitled "Diffuse Light Reflectance Readhead"), and 5,611,999 (entitled "Diffuse Light Reflectance Readhead"). It is contemplated that other colorimetric or optical devices may be used. [0020] Referring next to FIG. 4, a test device 20 having an electrochemical measuring unit 42 is illustrated according to an alternate embodiment of the present invention. In an electrochemical assay, the reagent is designed to react with glucose in the blood to create an oxidation current at electrodes 44 that is directly proportional to the glucose concentration in the user's blood. The current is measured by the electrochemical measuring unit 42, that is electrically coupled to the electrodes 44. An example of an electrochemical testing system is described in detail by commonly-owned U.S. Patent No. 5,723,284 (entitled "Control Solution And Method For Testing The Performance Of An Analyte In Blood"). It is contemplated that other electrochemical testing systems may be used.

[0021] Referring now to FIG. 3 or 4, the test device 20 includes a processor 38 that is electrically coupled to the measuring unit 32 (FIG. 3) or the electrochemical measuring unit 42 (FIG. 4) and the power button 26a. The processor 38 calculates the blood glucose level and outputs the result to the display 28. The processor 38 is also connected to a removable memory 40 for storing information regarding glucose readings, such as the blood glucose level, the date of the measurement, and the time of the measurement. The processor 38 can also produce summaries, graphical or tabular text, of the stored data in graphical file formats and store the summaries in the removable memory device 40. It is further contemplated that in some embodiments the processor 38 also has a permanent memory to store information regarding test results. In some embodiments it is contemplated that a test device may comprise both a permanent memory and a removable memory.

[0022] The removable memory 40 allows a user to easily transfer the information stored in the memory 40 to a computer or a printer. Examples of removable memory 40 formats that may be used include, but are not limited to, COMPACT FLASH®, SMARTMEDIA™, MEMORY STICK®, XD-PICTURE CARD™, MULTIMEDIACARDS®, and SECURE DIGITAL™ ("SD™"). Due to the fact that SD™ is small in size and may be used with a serial peripheral interface, SD™ is well suited to be used as the removable memory 40 of the test device 20.

[0023] The processor 38 of the test device 20 communicates the information regarding the blood glucose readings to the removable memory 40 in file formats that are widely recognized by computers and printers, such as ASCII for individual test results or a table of test results, and JPEG or TIFF for graphical results. Graphical results are typically used when a user wishes to chart test results over a period of time to observe trends in blood glucose levels or determine modal days. The use of widely recognized file formats on the removable memory card 40 allows the user to easily transfer the data contained on the memory card 40 to a printer or a computer. Many printers now feature memory card readers and support JPEG and TIFF file formats so that photographs taken with digital cameras may be printed without the need for a computer. An example of such a printer is the PHOTOSMART 7960® printer manufactured by HE WLETT-P ACKARD®. Alternatively, a user could use a photo kiosk at a camera center or retail outlet to eliminate the need to have their own printer. Allowing the user to print results directly from the removable memory 40 simplifies the process a user must follow to obtain a hardcopy of the results of blood glucose analysis. The user no longer has to use cables to transfer data out of the test device and into a printer or computer, which can be a frustrating experience for the user. Additionally, by having the processor 38 of the device 20 store the results of the testing onto the removable memory 40 in a file format that is supported by many software programs and printers, the user does not have to manipulate the data to obtain useable information. Using common file formats for the data stored in the removable memory 40 also eliminates the need for costly software to process the data produced by the testing device 20.

[0024] Additionally, the hardcopy makes it easier for the user to share testing results with healthcare providers, increasing the amount of information the healthcare provider has to assist the user in blood glucose management. Providing the healthcare provider with additional information allows the user to obtain better medical advice, leading to greater control of the user's blood glucose level.

[0025] Turning now to FIG. 5, an embodiment of the display 28 will be described. In this embodiment, the display 28 includes a bar-graph display 50 made up of a plurality of boxes 52. The vertical axis of the bar-graph display represents the glucose concentration in the sample, while the horizontal axis represents the time that the sample was obtained, hi this embodiment, the bar-graph includes six boxes 52 arranged vertically to represent six different ranges of glucose readings. For example, each box may represent a range of approximately 75 mg/dL.

[0026] In this embodiment, the bar-graph also includes two horizontal lines 54a, 54b. The two lines 54a, 54b are shown to illustrate to the user a "normal" or average glucose concentration. The boxes 56 above the line 54a indicate "high" glucose concentrations, while the boxes 56 below the line 54b indicate "low" glucose readings.

[0027] Below the bar-graph, a numerical display 56 indicates the date, time, and exact concentration of a most current sample 58. Using the control buttons 26b-26e (FIGS. 2-4), the user may scroll from the most recent sample through past samples. The data for the past samples are stored in the removable memory 40 (FIG. 2) of the test device 20. As the user scrolls, the display screen will highlight the various samples, according to one embodiment. It is also contemplated that the numerical display 56 will display the exact concentration level and the date and time when the highlighted sample was measured.

[0028] As the information displayed in the bar-graph display 50 is stored in the removable memory 40, the user may obtain a hardcopy of the bar-graph display 50 by removing the removable memory 40 and placing the removable memory 40 directly in a printer or a computer, hi some embodiments, the hardcopy of the bar-graph display 50 will include a table of the exact concentration of all of the samples on the bar-graph display 50, as well as the date and time when the sample was measured. In this manner, all of the information typically stored in the removable memory 40 is recorded on the hardcopy of the bar-graph display. It is also contemplated that in some embodiments the display 28 will display a bar-graph that does not include discreet boxes 52, but rather shows continuous bars that represent the glucose reading. It is further contemplated that in an alternate embodiment data stored to a removable memory will allow a hardcopy of the data to be created that contains a higher resolution and additional data not shown on a display of the device. [0029] According to another embodiment of the present invention, the display 28 of the test device 20 of the present invention may only be an alphanumeric display. By having the display 28 only be an alphanumeric display the cost of producing the test device 20 may be greatly reduced. The processor 38 is able to store and process the test results to the removable memory 40 in a form that allows the user to simply transfer the data stored in the removable memory 40 to a computer or a printer. The processor 38 may alternatively store a summary of all test results to allow a user to obtain a summary of the test results, hi this manner the user may still obtain a hardcopy of a graphical representation of all test results stored on the removable memory 40, but the device 20 does not need to have a costly display capable of displaying graphical results.

[0030] In some embodiments, the graph may be a line graph 62, such as the one shown in FIG. 6. FIG. 6 illustrates a hardcopy 60 with the line graph 62 and the table of results 66. Each glucose concentration sample is indicated by a point 64 on the graph 62. [0031] As the information displayed in the line graph 62 and the table of results 66 is stored in the removable memory 40, the user may obtain the hardcopy 60 of the results by removing the removable memory 40 and placing the removable memory 40 directly in a printer or a computer. In this manner, all of the information typically stored in the removable memory 40 is recorded on the hardcopy of the line graph. In an alternate embodiment, it is contemplated that the hardcopy may only contain a line graph to provide the test results. In another alternate embodiment of the present invention, it is contemplated that the hardcopy may only contain the table of results to provide the test results.

[0032] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. [0033] ALTERNATIVE EMBODIMENT A

A test device for determining an analyte concentration in a liquid sample, the test device comprising: a measuring unit adapted to measure the reaction of a reagent and the analyte and to generate a signal indicative of the measured reaction; a processor electronically coupled to the measuring unit, the processor being adapted to determine the analyte concentration in the sample in response to receiving the signal indicative of the measured reaction from the measuring unit; a removable memoiy device electronically coupled to the processor for storing the analyte concentrations, the removable memory device including storage of a current sample concentration and at least one prior sample concentration; and a user display electronically coupled to the processor for displaying the analyte concentration of the current sample.

[0034] ALTERNATIVE EMBODIMENT B

The test device of Alternative Embodiment A wherein the removable memory device is a memory card. [0035] ALTERNATIVE EMBODIMENT C

The test device of Alternative Embodiment B wherein the memory card is a COMPACT FLASH memory card. [0036] ALTERNATIVE EMBODIMENT D

The test device of Alternative Embodiment B wherein the memory card is a SMARTMEDIA memory card. [0037] ALTERNATIVE EMBODIMENT E

The test device of Alternative Embodiment B wherein the memory card is a MEMORY STICK memory card. [0038] ALTERNATIVE EMBODIMENT F

The test device of Alternative Embodiment B wherein the memory card is a XD- PICTURE CARD memory card. [0039] ALTERNATIVE EMBODIMENT G

The test device of Alternative Embodiment B wherein the memory card is a MULTIMEDIACARDS memory card. [0040] ALTERNATIVE EMBODIMENT H

The test device of Alternative Embodiment B wherein the memory card is a SECURE DIGITAL memory card. [0041] ALTERNATIVE EMBODIMENT I

The test device of Alternative Embodiment A wherein the removable memory device stores the analyte concentration of the sample as an ASCII file. [0042] ALTERNATIVE EMBODIMENT J

The test device of Alternative Embodiment A wherein the removable memory device stores a summary of the analyte concentration data from a plurality of samples as a graph in a graphical file format. [0043] ALTERNATIVE EMBODIMENT K

The test device of Alternative Embodiment A wherein the removable memory device stores a summary of the analyte concentration data from a plurality of samples as a text table in a graphical file format. [0044] ALTERNATIVE EMBODIMENT L

The test device of Alternative Embodiment A wherein the display displays the analyte concentration of the current sample in numerical form. [0045] ALTERNATIVE EMBODIMENT M

The test device of Alternative Embodiment A wherein the display further displays the analyte concentration of the current sample and at least one prior sample in a graph. [0046] ALTERNATIVE EMBODIMENT N

The test device of Alternative Embodiment A wherein the removable memory device contains numeric data regarding the current sample and the at least one prior sample. [0047] ALTERNATIVE EMBODIMENT O

The test device of Alternative Embodiment A wherein the removable memory device stores the results as a bar-graph. [0048] ALTERNATIVE EMBODIMENT P

The test device of Alternative Embodiment A wherein the removable memory device stores the results as a line graph. [0049] ALTERNATIVE EMBODIMENT Q

The test device of Alternative Embodiment A wherein the removable memory device stores the results as a JPEG file. [0050] ALTERNATIVE EMBODIMENT R

The test device of Alternative Embodiment A wherein the removable memory device stores the results as a TIFF file. [0051] ALTERNATIVE EMBODIMENT S

The test device of Alternative Embodiment A wherein the sample is blood. [0052] ALTERNATIVE EMBODIMENT T

The test device of Alternative Embodiment A wherein the analyte is glucose. [0053] ALTERNATIVE EMBODIMENT U

The test device of Alternative Embodiment A wherein the processor further includes a permanent memory. [0054] ALTERNATIVE PROCESS V

A method for obtaining a hard copy of a plurality of sample results stored on a test device, the test device having a removable memory device in which an analyte concentration of at least one past sample is stored, the test device being adapted to receive a test sensor for collecting the sample, the test sensor containing a reagent adapted to produce a reaction indicative of the analyte concentration in the sample, the method comprising the acts of: measuring the reaction between the analyte in a current sample and the reagent contained in the test sensor; determining the concentration of the analyte in the current sample; storing the concentration of the analyte in the current sample in the removable memory device; removing the removable memory device from the test device; inserting the removable memory device into a memory device reader; and reading the stored results in the removable memory device with the memory device reader. [0055] ALTERNATIVE PROCESS W

The method of Alternative Process V wherein the storing the concentration of the analyte is in an ASCII format. [0056] ALTERNATIVE PROCESS X

The method of Alternative Process V wherein the storing the concentration of the analyte is in a JPEG format. [0057] ALTERNATIVE PROCESS Y

The method of Alternative Process V wherein the storing the concentration of the analyte is in a TIFF format. [0058] ALTERNATIVE PROCESS Z

The method of Alternative Process V wherein the memory device reader is in a computer. [0059] ALTERNATIVE PROCESS AA

The method of Alternative Process V further comprising the act of printing the stored results with a printer. [0060] ALTERNATIVE PROCESS BB

The method of Alternative Process AA wherein the memory device reader is in the printer. [0061] ALTERNATIVE PROCESS CC

The method of Alternative Process AA wherein the printing the stored results is in a graphical form. [0062] ALTERNATIVE PROCESS DD

The method of Alternative Process CC wherein the graphical form is a bar-graph. [0063] ALTERNATIVE PROCESS EE

The method of Alternative Process CC wherein the graphical form is a line graph. [0064] ALTERNATIVE PROCESS FF

The method of Alternative Process AA wherein the printing the stored results is in a alphanumerical form. [0065] ALTERNATIVE PROCESS GG

The method of Alternative Process AA wherein the printing the stored results is in a graphical form and an alphanumerical form. [0066] ALTERNATIVE PROCESS HH

The method of Alternative Process V wherein the measuring comprises measuring an optical reaction. [0067] ALTERNATIVE PROCESS II

The method of Alternative Process V wherein the measuring comprises measuring a colorimetric reaction. [0068] ALTERNATIVE PROCESS JJ

The method of Alternative Process V wherein the measuring comprises measuring an electrochemical reaction. [0069] ALTERNATIVE PROCESS KK

The method of Alternative Process V wherein the sample is blood. [0070] ALTERNATIVE PROCESS LL

The method of Alternative Process V wherein the analyte is glucose.

Claims

WHAT IS CLAIMED IS:

1. A test device for determining an analyte concentration in a liquid sample, the test device comprising: a measuring unit adapted to measure the reaction of a reagent and the analyte and to generate a signal indicative of the measured reaction;

5 a processor electronically coupled to the measuring unit, the processor being adapted to determine the analyte concentration in the sample in response to receiving the signal indicative of the measured reaction from the measuring unit; a removable memory device electronically coupled to the processor for storing the analyte concentrations, the removable memory device including storage of a o current sample concentration and at least one prior sample concentration; and a user display electronically coupled to the processor for displaying the analyte concentration of the current sample.

2. The test device of claim 1, wherein the removable memory device is a memory card. s 3. The test device of claim 2, wherein the memory card is a COMPACT

FLASH memory card.

4. The test device of claim 2, wherein the memory card is a SMARTMEDIA memory card.

5. The test device of claim 2, wherein the memory card is a MEMORY Q STICK memory card.

6. The test device of claim 2, wherein the memory card is a XD- PICTURE CARD memory card.

7. The test device of claim 2, wherein the memory card is a MULTIMEDIACARDS memory card. ₅ 8. The test device of claim 2, wherein the memory card is a SECURE

DIGITAL memory card.

9. The test device of claim 1, wherein the removable memory device stores the analyte concentration of the sample as an ASCII file.

10. The test device of claim 1, wherein the removable memory device Q stores a summary of the analyte concentration data from a plurality of samples as a graph in a graphical file format.

11. The test device of claim 1, wherein the removable memory device stores a summary of the analyte concentration data from a plurality of samples as a text table in a graphical file format.

12. The test device of claim 1, wherein the display displays the analyte concentration of the current sample in numerical form.

13. The test device of claim 1, wherein the display further displays the analyte concentration of the current sample and at least one prior sample in a graph.

14. The test device of claim 1, wherein the removable memory device contains numeric data regarding the current sample and the at least one prior sample.

15. The test device of claim 1, wherein the removable memory device stores the results as a bar-graph.

16. The test device of claim 1, wherein the removable memory device stores the results as a line graph.

17. The test device of claim 1, wherein the removable memory device stores the results as a JPEG file.

18. The test device of claim 1, wherein the removable memory device stores the results as a TIFF file.

19. The test device of claim 1, wherein the sample is blood.

20. The test device of claim 1, wherein the analyte is glucose.

21. The test device of claim 1, wherein the processor further includes a permanent memory.

22. A method for obtaining a hard copy of a plurality of sample results stored on a test device, the test device having a removable memory device in which an analyte concentration of at least one past sample is stored, the test device being adapted to receive a test sensor for collecting the sample, the test sensor containing a reagent adapted to produce a reaction indicative of the analyte concentration in the sample, the method comprising the acts of: measuring the reaction between the analyte in a current sample and the reagent contained in the test sensor; determining the concentration of the analyte in the current sample; storing the concentration of the analyte in the current sample in the removable memory device; removing the removable memory device from the test device; inserting the removable memory device into a memory device reader; and reading the stored results in the removable memory device with the memory device reader.

23. The method of claim 22, wherein the storing the concentration of the analyte is in an ASCII format.

24. The method of claim 22, wherein the storing the concentration of the analyte is in a JPEG format.

25. The method of claim 22, wherein the storing the concentration of the analyte is in a TIFF format.

26. The method of claim 22, wherein the memory device reader is in a computer.

27. The method of claim 22 further comprising the act of printing the stored results with a printer.

28. The method of claim 27, wherein the memory device reader is in the printer.

29. The method of claim 27, wherein the printing the stored results is in a graphical form.

30. The method of claim 29, wherein the graphical form is a bar-graph.

31. The method of claim 29, wherein the graphical form is a line graph.

32. The method of claim 27, wherein the printing the stored results is in a alphanumerical form.

33. The method of claim 27 wherein the printing the stored results is in a graphical form and an alphanumerical form.

34. The method of claim 22, wherein the measuring comprises measuring an optical reaction.

35. The method of claim 22, wherein the measuring comprises measuring a colorimetric reaction.

36. The method of claim 22, wherein the measuring comprises measuring an electrochemical reaction.

37. The method of claim 22, wherein the sample is blood.

38. The method of claim 22, wherein the analyte is glucose.