BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1813408 · Received August 19, 2010

    Report

    Report Number
    2027969-2010-01241
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 1.6; RE-TEST: 2.9. THE TWO RESULTS WERE TAKEN WITHIN 30 MINS OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 232167

    Patients

    Seq Age Sex Outcome Treatment
    1