BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 838590 · Received February 16, 2007

    Report

    Report Number
    2954730-2007-00083
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 14, 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: SEE SCANNED TABLE. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST, THIRD, AND THE LAST SETS OF DATA, INRATIO VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED. THE TEST RESULTS RETAINS STRIPS LOT 060201 IN 2006, ARE AS FOLLOWS: SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, PER PR 0103, RETAINED LOT 060201 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007 INRATIO 1.6 LAB 3.6; INRATIO 1.9 LAB 3.6; INRATIO 1.5 LAB 3.6; INRATIO 1.6 LAB 3.1 (COAGUCHEK); INRATIO 1.9 LAB 3.1 (COAGUCHEK); INRATIO 1.5 LAB 3.1 (COAGUCHEK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060201

    Patients

    Seq Age Sex Outcome Treatment
    1 *