BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 828309 · Received February 28, 2007

    Report

    Report Number
    2954730-2007-00100
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 27, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: 2/20/07: INRATIO 6.4, LAB 4.1, MEAN 5.25, CONFIDENCE LIMITS UNABLE TO BE DETERMINED. 2/20/07: INRATIO 6.1, LAB 4.1, MEAN 5.10, CONFIDENCE LIMITS UNABLE TO BE DETERMINED. TS UPDATED 2/23/2007. 2/23/2007: INRATIO 3.7, LAB 2.7, MEAN 3.2, CONFIDENCE LIMITS 1.9-4.6. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE FIRST SET OF READINGS IS CONSIDERED INACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. FOR THE SECOND SET OF READINGS, BOTH INRATIO AND LAB VALUES ARE WITHIN CONSIDERED ACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. THE LAST SET OF READINGS, DATED 2/23/2007, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: 2/20/07: LAB 4.1, INRATIO 6.4 AND 6.1. 2/23/07: LAB 2.7, INRATIO 3.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060685

    Patients

    Seq Age Sex Outcome Treatment
    1 *