BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1972935 · Received January 19, 2011

    Report

    Report Number
    2027969-2011-00134
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL = 2.1 AND REPEAT = 1.0. SEVERAL CHANGES IN MEDICATIONS (NO ADJUSTMENT TO COUMADIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 236690

    Patients

    Seq Age Sex Outcome Treatment
    1