Host apparatus and method providing calibration and reagent information to a measurement apparatus which makes use of a consumable reagent in a measuring process

• US RE44,345 E1
• Filed: 05/16/2006
• Issued: 07/09/2013
• Est. Priority Date: 05/17/2005
• Status: Active Grant

• Current Assignee: Roche Operations Limited (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Ackermann, Friedrich Karl, Augstein, Manfred, Beck, Timothy L., Fuerst, Markus Stephan, Meek, Robert Lawrence, Ramey, Blaine Edward, Sabo, Robert Paul, Sauers, Matthew Carlyle, Schreiber, Joerg, Walter, Wolfgang, Williams, Seth Faulkner, Wittekind, Frederick Leland III, Pash, Philip Edgar
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US13/362,011
• Time in Patent Office: 2,611 Days
• Field of Search: 235/439, 235/472.01, 600/300, 600/301, 702/30
• US Class Current: 235/439
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Apparatuses and methods providing data such as, for example, calibration and reagent information (30) over a network (6) to a measurement apparatus (4) which makes use of a consumable reagent (18) in a measuring process are disclosed. The present invention permits a measurement apparatus (4) to download the necessary code assignment (24) and calibration data (32) of the consumable reagent (18) by means of an electronic communication protocol from a host (33). The host (33) can be a software application running on a host computer (34), another measurement apparatus (50, 58) with or without a code-key slot used to read a memory device providing the above mentioned information (30), a dedicated connectivity device, such as a docking station (44), a portable memory reader (48), a remote computer (54), and combinations thereof.

Claims

1. A measurement system comprising:

a network;

a measurement apparatus provided with a first set of lot data files containing calibration data and lot identification codes each associated with respective ones of the calibration data, said measurement apparatus uses a consumable reagent in a measurement process, said consumable reagent having an associated lot data file containing calibration data and associated lot identification codes each associated with respective ones of the calibration data, wherein said measurement apparatus transmits over said network said associated lot data file of said consumable reagent when said associated lot identification codes fail to match any of said lot identification codes of the first set of lot data files provided on the measurement apparatus; and

a host apparatus provided with a second set of lot data files containing calibration data and lot identification codes each associated with respective ones of the calibration data, said host apparatus receives said associated lot data file containing the associated lot identification codes each associated with respective calibration data of said consumable reagent transmitted from said measurement apparatus over said network, to subsequently identify whether the associated lot identification codes in the received lot data file match any of the lot identification codes of the second set of lot data files, and to distribute said lot data file of said consumable reagent containing the calibration data and the lot identification codes each associated with respective ones of the calibration data via the network when one of said associated lot identification codes matches one of the lot identification codes of the second set of lot data files.

2. The measurement system of claim 1 wherein said network is an in-building wireless network.

3. The measurement system of claim 1 wherein said network is a wired network.

4. The measurement system of claim 1 wherein said network is a peer-to-peer connection.

5. The measurement system of claim 1 wherein said network is selected from a group comprising an in-building wireless network, a wired network, a peer-to-peer connection, and combinations thereof.

6. The measurement system of claim 1 wherein said measurement apparatus is a handheld diagnostic device.

7. The measurement system of claim 1 wherein said measurement apparatus is a clinical chemistry analyzer.

8. The measurement system of claim 1 wherein said measurement apparatus comprises a lot identification code reader which is configured to read said associated lot data file of said consumable reagent.

9. The measurement system of claim 1 wherein said associated lot data file is provided in a machine-readable memory, and said measurement apparatus communicates with a reader for the machine-readable memory which reads said machine-readable memory in order to provide said associated lot data file to said measurement apparatus.

10. The measurement system of claim 1 wherein said measurement apparatus comprises a lot identification code reader which is configured to read said associated lot data file of said consumable reagent, wherein said associated lot data file is a radio frequency identification tag, and said lot identification code reader is a radio frequency identification tag reader.

11. The measurement system of claim 1 wherein said measurement apparatus comprises a lot identification code reader which reads said associated lot data file of said consumable reagent, wherein said associated lot data file is a magnetic identification tag, and said lot identification code reader is a magnetic identification tag reader.

12. The measurement system of claim 1 wherein said measurement apparatus comprises a lot identification code reader which reads said associated lot data file of said consumable reagent, said consumable reagent being provided on a disposable strip and said associated lot data file being provided on a container providing said disposable strip.

13. The measurement system of claim 1 wherein said measurement apparatus comprises a lot identification code reader which reads said associated lot data file of said consumable reagent, said consumable reagent being provided on a disposable strip and said associated lot data file being provided on said disposable strip.

14. The measurement system of claim 1 wherein said host apparatus is a data management system.

15. The measurement system of claim 1 wherein said host apparatus is another measurement apparatus.

16. The measurement system of claim 1 wherein said host apparatus is a computer station.

17. The measurement system of claim 1 wherein said host apparatus is a docking station.

18. The measurement system of claim 1 wherein said host apparatus is a reader for a machine-readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips.

19. The measurement system of claim 1 wherein said second set of lot data files is provided in memory of said host apparatus, wherein said memory is a machine-readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips.

20. The measurement system of claim 1 wherein said second set of lot data files is provided in memory of said host apparatus, wherein said memory is a machine readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips, and said host apparatus is a docking station.

21. The measurement system of claim 1 wherein said host apparatus has access to memory which contains said second set of lot data files.

22. The measurement system of claim 1 further comprising a database in communication with said host apparatus, said database containing said second set of lot data files.

23. The measurement system of claim 1 further comprising a database in communication with said host apparatus over a public network, said database containing said second set of lot data files.

24. The measurement system of claim 1 wherein said measurement apparatus has a display and calculates a test result using calibration data associated with one of said associated lot identification codes and displays said test result on said display.

25. The measurement system of claim 1 wherein said calibration data is specific to one or more lots of a consumable reagent.

26. The measurement system of claim 1 wherein said host apparatus calculates a test result using calibration data associated with one of said lot identification codes in said second set of lot data files, and provides the test result to said measurement apparatus.

27. A method of deriving a test result using a measurement apparatus and a consumable reagent, the method comprising:

providing a network;

providing a consumable reagent together with an associated lot data file containing calibration data and associated identification codes each associated with respective ones of the calibration data;

providing said measurement apparatus with a first set of lot data files containing calibration data and identification codes each associated with respective ones of the calibration data provided therewith;

providing a host apparatus with a second set of lot data files containing calibration data and identification codes each associated with respective ones of the calibration data provided therewith;

reading said associated lot data file of said consumable reagent with said measurement apparatus;

transmitting over said network said associated lot data file of said consumable reagent to said host apparatus when said associated lot identification codes of said consumable reagent fail to match any of said lot identification codes of the first set of lot data files provided on the measuring apparatus;

identifying with said host apparatus whether the associated lot identification codes of the received first set of lot data files match any of the lot identification codes of the second set of lot data files;

distributing said lot data file of said consumable reagent via the network from the host apparatus when one of said associated lot identification codes matches one of the lot identification codes of the second set of lot data files; and

deriving the test result using the measurement apparatus, the consumable reagent, and the calibration data associated with said associated lot identification code received from the host apparatus.

28. The method of claim 27 wherein said network is an in-building wireless network.

29. The method of claim 27 wherein said network is a wired network.

30. The method of claim 27 wherein said network is a peer-to-peer connection.

31. The method of claim 27 wherein said network is selected from a group comprising an in-building wireless network, a wired network, a peer-to-peer connection, and combinations thereof.

32. The method of claim 27 wherein said measurement apparatus is a blood glucose meter.

33. The method of claim 27 wherein said measurement apparatus comprises a reader, and said method further comprises reading with said reader said associated lot data file of said consumable reagent.

34. The method of claim 27 wherein said measurement apparatus comprises a lot identification code reader, and said method further comprises reading with said reader an associated lot identification code having at least calibration data associated therewith of said consumable reagent, wherein said associated lot identification code having at least calibration data associated therewith is a barcode, and said lot identification code reader is a barcode reader.

35. The method of claim 27 wherein said measurement apparatus comprises a lot identification code reader, and said method further comprises reading with said reader an associated lot identification code having at least calibration data associated therewith of said consumable reagent, wherein said associated lot identification code having at least calibration data associated therewith is a radio frequency identification tag, and said lot identification code reader is a radio frequency identification tag reader.

36. The method of claim 27 wherein said measurement apparatus comprises a lot identification code reader, and said method further comprises reading with said reader an associated lot identification code having at least calibration data associated therewith of said consumable reagent, wherein said associated lot identification code having at least calibration data associated therewith is a magnetic identification tag, and said lot identification code reader is a magnetic identification tag reader.

37. The method of claim 27 wherein said measurement apparatus comprises a lot identification code reader, and said method further comprises reading with said reader an associated lot identification code having at least calibration data associated therewith of said consumable reagent, said consumable reagent being provided on a disposable strip and said associated lot identification code having at least calibration data associated therewith being provided on a container providing said disposable strip.

38. The method of claim 27 wherein said measurement apparatus comprises a lot identification code reader, and said method further comprises reading with said reader an associated lot identification code having at least calibration data associated therewith of said consumable reagent, said consumable reagent being provided on a disposable strip and said associated lot identification code having at least calibration data associated therewith being provided on said disposable strip.

39. The method of claim 27 wherein said host apparatus is a data management system.

40. The method of claim 27 wherein said host apparatus is another measurement apparatus.

41. The method of claim 27 wherein said host apparatus is a computer station.

42. The method of claim 27 wherein said host apparatus is a docking station.

43. The method of claim 27 wherein said host apparatus is a reader for a machine-readable memory which is removed from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips.

44. The method of claim 27 further comprises providing said second set of lot data files in memory of said host apparatus, wherein said memory is a removable machine-readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips.

45. The method of claim 27 further comprises providing said second set of lot data files in memory of said host apparatus, wherein said memory is a removable machine readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips, and said host apparatus is a docking station.

46. The method of claim 27 further comprising said host apparatus accessing memory which contains said second set of lot data files.

47. The method of claim 27 further comprising said host apparatus communicating with a database, said database containing said second set of lot data files.

48. The method of claim 27 further comprising said host apparatus communicating with a database over a public network, said database containing said second set of lot data files.

49. The method of claim 27 wherein said measurement apparatus has a display and said method further comprises said measurement apparatus calculating a test result using said calibration data associated with said associated lot identification code and displaying said test result on said display.

50. The method if claim 27 wherein if there is not a match between said associated lot identification code with any one of the lot identification codes contained in the first set of lot data files, said method further comprises displaying a message on said measurement apparatus indicating that said reagent is not authorized for use.

51. The method of claim 27 wherein if there is not a match between said associated lot identification code with any one of the lot identification codes contained in the first set of lot data files, said method further comprises displaying a message on said measurement apparatus indicating that said reagent is not authorized for use, and sending a similar message to a designated personnel such that corrected action may be taken.

52. The method of claim 27 wherein said associated lot identification code has an associated expiration date, wherein said method further comprises displaying on said measurement apparatus a message indicating said reagent is unauthorized for use after said expiration date has expired.

53. The method of claim 27 wherein said measurement apparatus is a clinical chemistry analyzer.

54. The method of claim 27 wherein said calibration data is specific to one or more lots of said consumable reagent.

55. A measurement system using a consumable reagent, said system comprising:

a machine-readable memory removable from one of the reagent, a test strip which provides the reagent, and a container which provides a plurality of test strips, said memory containing a lot data associated with a consumable reagent, said lot data file containing calibration data and lot identification codes each associated with respective ones of the calibration data provided therewith;

a reader which interfaces with the machine-readable memory and reads said lot data file of said consumable reagent from said removable machine-readable memory; and

a measurement apparatus remote from said reader and which uses said consumable reagent in a measurement process, wherein said measurement apparatus communicates with said reader to receive said lot data file associated with said consumable reagent.

56. The measurement system of claim 55, wherein said reader is portable.

57. The measurement system of claim 55, wherein said measurement apparatus and said lot reader are configured to communicate wirelessly.

58. The measurement system of claim 55, wherein said reader is portable, and said measurement apparatus and said reader are configured to communicate wirelessly.