BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2001828 · Received February 16, 2011

    Report

    Report Number
    2027969-2011-00348
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: >7.5, LAB: 4.0, THERAPEUTIC RANGE: 2-3. PT TREATED ON BLOOD DRAW. THE RESULTS DRAWN WITHIN 2 HOURS OF EACH OTHER. COUMADIN TAKEN IN AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100139 236690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other