BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220013 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01544
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.8, LAB: 2.4, UNK AMOUNT OF TIME BETWEEN TESTS. DATE: (B)(6) 2011, 4.8, 2.6. TESTS ON (B)(6) 2011, UNK AMOUNT OF TIME BETWEEN TESTS. TESTS ON (B)(6) 2011, WERE PERFORMED WITHIN 10 MINUTES 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 248203

    Patients

    Seq Age Sex Outcome Treatment
    1