BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2852143 · Received November 12, 2012

    Report

    Report Number
    2027969-2012-01605
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    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:" INR = 3.2, 6.0. TESTING PERFORMED WITHIN MINUTES. THERAPEUTIC RANGE: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 289242

    Patients

    Seq Age Sex Outcome Treatment
    1 PREDNISONE FOR 1.5 MONTHS FOR THE TEMPLAR ARTERITI| COUMADIN