BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1874377 · Received October 12, 2010

    Report

    Report Number
    2027969-2010-01701
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS COMPARED WITH ANOTHER INRATIO METER. RESULTS AS FOLLOWS: PATIENT: 2, INRATIO A: 6.0, INRATIO B: 4.9, (RE-TEST) INRATIO A: 3.2. THE SAME FINGER STICK WAS USED FOR ALL THREE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234589

    Patients

    Seq Age Sex Outcome Treatment
    1