Method and system for checking an electromechanical biosensor

• US 8,496,801 B2
• Filed: 07/24/2006
• Issued: 07/30/2013
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Huang, Dijia
• Primary Examiner(s): Hendricks, Keith
• Assistant Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US11/988,426
• Publication Number:
  US 20090127135A1
• Time in Patent Office: 2,563 Days
• Field of Search: 204400-435, 205775-7945, 73 5301- 6456, 435 4- 4052, 4352871-2887, 436 62- 71, 436500-548
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

A method of operating a meter for determining the concentration of an analyte in a current sample and for self-detecting electrical connection errors like short or open circuit between the electrodes of a biosensor. The method includes providing a connector with a plurality of contacts and coupling each of the plurality of contacts to one of a plurality of electrical leads on a biosensor, such that each of the plurality of connector contacts electrically contacts a corresponding one of the plurality of electrical leads. The meter obtains a first measurement between a pair of the plurality of connector contacts prior to the fluid sample being applied. The meter also obtains a second measurement between the pair of the plurality of connector contacts after the fluid sample is applied. In response to either the first or the second measurements being outside a predetermined range, a fault is indicated.

Claims

1. A method of operating a meter for determining the concentration of an analyte in a fluid sample, the method comprising the acts of:

providing a biosensor and a meter;

providing a connector in the meter with a plurality of connector contacts;

positioning a biosensor in the meter, the biosensor including a plurality of leads, at least two of the plurality of leads being configured to contact at least one of the plurality of connector contacts in the meter;

obtaining a first measurement between at least one pair of the plurality of connector contacts via the meter prior to the fluid sample being applied;

determining if a short condition exists based on the first measurement;

obtaining a second measurement between at least one pair of the plurality of connector contacts via the meter after the fluid sample is applied; and

determining if an open condition exists based on the second measurement.

2. The method of claim 1, wherein the first and second measurements obtained are current measurements.

3. The method of claim 2, wherein a fault exists if the first measurement prior to the sample being applied is greater than about 20 nA.

4. The method of claim 2, wherein an open condition exists if the second measurement after the sample is applied being less than about 200 nA.

5. The method of claim 1, further comprising applying a voltage to each pair, one pair at a time, of the plurality of connector contacts via the meter.

6. The method of claim 5, wherein the voltage is from about 0.2 to about 3.0 volts.

7. The method of claim 1, wherein the meter obtains a measurement between each pair, one at a time, of the plurality of connector contacts.

15. The method of claim 1, wherein the short condition exists when at least one of the plurality of connector contacts is in contact with two or more of the plurality of leads when the biosensor is positioned in the meter, and the open condition exists when at least one of the plurality of connector contacts is not in contact with any of the plurality of leads when the biosensor is positioned in the meter.

19. The method of claim 15, further comprising indicating a fault if it is determined that at least one of the plurality of connector contacts is in contact with two or more of the plurality of leads or one of the plurality of connector contacts is not in contact with any of the plurality of the leads.

8. A method of operating a meter for determining the concentration of an analyte in a fluid sample, the method comprising the acts of:

positioning a biosensor in the test position, the biosensor including a plurality of leads, the plurality of leads contacting one of a plurality of connector contacts in the meter;

obtaining a first current measurement between a pair of the of the plurality of connector contacts via the meter;

after obtaining the first current measurement, introducing a fluid sample into the meter;

obtaining a second current measurement between the pair of the plurality of connector contacts via the meter after the fluid sample is applied;

in response to the first current measurements being outside a predetermined range, indicating a short condition fault; and

in response to the second current measurements being outside a predetermined range, indicating an open condition fault.

16. The method of claim 8, wherein the short condition fault is indicative of at least one of the plurality of connector contacts being in contact with two or more of the plurality of leads when the biosensor is positioned in the test position, and the open condition fault is indicative of at least one of the plurality of connector contacts being not in contact with any of the plurality of leads when the biosensor is positioned in the test position.

9. A test system for determining the concentration of an analyte in a fluid sample, the system comprising:

a meter having a connector with a plurality of contacts; and

a biosensor having a plurality of leads, at least two of the plurality of leads being configured to contact at least two of the plurality of connector contacts;

wherein the meter is configured to take a first measurement between a pair of the plurality of connector contacts prior to the fluid sample being applied and a second measurement after the fluid sample is applied, to determine if a short condition exists based on the first measurement, and to determine if an open condition exists based on the second measurement.

10. The system of claim 9, wherein the measurement obtained is the current between the pair of the plurality of connector contacts.

11. The system of claim 10, wherein a fault exists if the measurement prior to the fluid sample is applied is greater than about 20 nA.

12. The system of claim 10, wherein an open condition exists if the measurement after the fluid sample is applied is less than about 200 nA.

13. The system of claim 9, wherein the meter is adapted to apply a voltage to each pair, one pair at a time, of the plurality of connector contacts, one pair at a time.

14. The system of claim 13, wherein the voltage is between about 0.2 and 3.0 volts.

17. The test system of claim 9, wherein the short condition exists when at least one of the plurality of connector contacts is in contact with two or more of the plurality of leads, and the open condition exists when at least one of the plurality of connector contacts is not in contact with any of the plurality of leads.

20. The test system of claim 17, wherein the meter is further adapted to indicate a fault if it is determined that at least one of the plurality of connector contacts is in contact with two or more of the plurality of leads or one of the plurality of connector contacts is not in contact with any of the plurality of the leads.

18. A method of operating a meter for determining the concentration of an analyte in a fluid sample, the method comprising the acts of:

providing a biosensor and a meter;

providing a connector in the meter with a plurality of connector contacts;

positioning a biosensor in the meter, the biosensor including a plurality of leads, at least two of the plurality of leads being configured to contact at least a respective one of the plurality of connector contacts in the meter;

obtaining a first measurement between at least one pair of the plurality of connector contacts via the meter prior to the fluid sample being applied;

determining whether at least one of the plurality of connector contacts is in contact with two or more of the plurality of leads based on the first measurement obtained prior to the fluid sample being applied, the determining based on the first measurement prior to the fluid sample being applied including determining whether an open condition exists;

obtaining a second measurement between at least one pair of the plurality of connector contacts via the meter after the fluid sample is applied; and

determining whether at least one of the plurality of connector contacts is not in contact with any of the plurality of leads based on the second measurement obtained after the fluid sample is applied, the determining based on the second measurement after the fluid sample is applied including determining whether a short condition exists.