SYSTEM FOR MEASURING AN ANALYTE CONCENTRATION OF A BODY FLUID SAMPLE

• US 20100119414A1
• Filed: 12/15/2009
• Published: 05/13/2010
• Est. Priority Date: 06/15/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Eikmeier, Heino, Eisenhardt, Christoph
• Granted Patent: US 8,628,721 B2
• Time in Patent Office: Days
• US Class Current: 422/68.100
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

A system is provided for measuring an analyte concentration in a body fluid sample, comprising at least one cartridge that contains consumables for multiple measurements, a data carrier which is affixed to the cartridge and contains calibration information for the consumables contained in the cartridge, a hand-held device that comprises a cartridge reception compartment including a reading facility for receiving a cartridge of this type and for reading its data carrier, a measuring facility for measuring the result of a detection reaction, a processor that is connected to the measuring facility and the reading facility for controlling the measuring facility and for analysis of a measuring signal. As an additional system component, at least one replaceable data storage unit is further provided in which supplementary data is stored. The data storage unit functions in combination with calibration information from the data carrier, wherein the hand-held device comprises an interface for transmission of supplementary data from the replaceable data storage unit to the device, and a consumables identification is stored on the data carrier and used by the processor after insertion of a cartridge to determine whether the consumables of the inserted cartridge, combined with the supplementary data that is available to the processor, renders a reliable measurement of an analyte concentration of a body fluid sample feasible.

Claims

1. A system for measuring an analyte concentration in a body fluid sample, comprising consumables with detection reagents that effect a detection reaction when exposed to the body fluid sample, at least one cartridge that contains consumables of this type for multiple measurements, a data carrier which is affixed to the cartridge and contains calibration information for the consumables contained in the cartridge, and a hand-held device that comprises a cartridge reception compartment including a reading facility for receiving a cartridge of this type and for reading its data carrier, a measuring facility for measuring the result of a detection reaction, a transport facility for moving consumables of the cartridge that is inserted in the cartridge reception compartment, for reception of a sample and measurement of the analyte concentration in the received body fluid sample, a processor that is connected to the measuring facility and the reading facility for controlling the measuring facility and for analysis of a measuring signal, and a memory that is connected to the processor and contains software for the processor, the system further comprising at least one replaceable data storage unit in which supplementary data is stored that functions in combination with the calibration information that is stored on the data carrier of the cartridge that is inserted in the device during the analysis of a measuring signal, the hand-held device comprising an interface for transmission of supplementary data from the replaceable data storage unit to the device, and a consumables identification being stored on the data carrier and configured to be used by the processor after insertion of the cartridge to check whether the calibration information of the data carrier affixed to the inserted cartridge matches the available supplementary data and thereby to enable the system to determine whether the consumables of the inserted cartridge combined with the supplementary data that is available to the processor renders a reliable measurement of an analyte concentration in the body fluid sample feasible, or if determined no feasible then to generate a signal in order to indicate to a user that the available supplementary data and the consumables of the inserted cartridge do not allow a valid measurement of an analyte concentration in the body fluid sample to be carried out.

2. The system according to claim 1, wherein the supplementary data is configured to effect a modification of evaluation algorithms stored in the memory of the hand-held device.

3. The system according to claim 1, wherein the supplementary data is configured to effect a modification of the software that is stored in the memory of the hand-held device.

4. The system according to claim 1, wherein the data carrier further comprises batch-specific data characterizing the consumables of a production batch stored thereon.

5. The system according to claim 1, wherein the data storage unit exclusively stores data that can be used for measurements using consumables from multiple cartridges.

6. The system according to claim 1, wherein the hand-held device comprises a reception compartment for the data storage unit in which supplementary data is stored, and a reading facility containing the interface for read-out of the data storage unit that is inserted in the reception compartment.

7. The system according to claim 6, wherein the hand-held device comprises a housing having a slit through which the data storage unit can be inserted into the reception compartment.

8. The system according to claim 5, wherein the data storage unit is affixed to the magazine.

9. The system according to claim 1, wherein less than 200 bit are stored on the data carrier.

10. The system according to claim 1, wherein the data storage unit stores in excess of 500 bit, or data.

11. The system according to claim 1, wherein the data carrier comprises one of a bar code and a magnetic memory.

12. The system according to claim 11, wherein the hand-held device comprises a bar code reader which comprises a CCD line.

13. The system according to claims 1, wherein the data carrier comprises an arrangement of resistors, wherein the calibration information is encoded by different resistance values.

14. The system according to claim 1, wherein the data storage unit is an EEPROM.

15. The system according to claim 1, wherein the data carrier carries a code comprising a plurality of differently colored areas.

18. A data storage unit for a system according to claim 1, wherein supplementary data are stored in the data storage unit, said supplementary data functioning in combination with a calibration information that is stored on a data carrier affixed to a cartridge containing consumables with detection reagents, and wherein by means of a consumables identification stored on the data carrier the unit is configured to check whether the calibration information of the data carrier matches the supplementary data stored on the data storage unit and thereby it can be determined whether a valid measurement of an analyte concentration in the body fluid sample is feasible with the consumables of the cartridge, to which the data carrier is fixed, in combination with the supplementary data of the data storage unit.

16. A cartridge with a data storage unit for a hand-held device for measuring an analyte concentration in a body fluid sample, the cartridge containing consumables with detection reagents for multiple measurements, said detection reagents effecting a detection reaction when exposed to the body fluid sample, wherein a data carrier is affixed to the cartridge, said data carrier containing calibration information for the consumables contained in the cartridge, supplementary data being stored in the data storage unit, said supplementary data functioning during the analysis of a measuring signal in combination with the calibration information that is stored in the data carrier of the cartridge inserted in the device, and a consumables identification being stored on the data carrier, said consumables identification being configured to allow the hand-held device to check whether the calibration information of the data carrier affixed to the cartridge matches the supplementary data stored in the data storage unit in order to determine whether a valid measurement of an analyte concentration in the body fluid sample can be carried out with the consumables of the cartridge in combination with the available supplementary data.

17. The cartridge according to claim 16, wherein the data storage unit is affixed to the magazine.