BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 896703 · Received July 13, 2007

    Report

    Report Number
    2954730-2007-00366
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    July 24, 2007
    Report Date
    August 9, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (UNKNOWN) 2007; INRATIO: 5.2, LAB: 3.76, MEAN: 4.48, CONFIDENCE LIMITS: 2.5 - 6.5; DATE: (070281) 2007; INRATIO: 4.7, LAB: 1.9, MEAN: 3.3, CONFIDENCE LIMITS: 2.0 - 5.0. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 1ST DATA SET, UNKNOWN STRIP LOT NUMBER, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. FOR THE SECOND DATA SET, STRIP LOT NUMBER 070281, THE LAB INR IS NOT WITHIN THE CONFIDENCE LIMITS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING OF STRIP LOT 070281 IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: (UNKNOWN) 2007, INRATIO: 5.2, LAB: 3.76; DATE: 2007; INRATIO: 4.7, LAB: 1.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070281

    Patients

    Seq Age Sex Outcome Treatment
    1 YR