BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3102674 · Received May 1, 2013

    Report

    Report Number
    2027969-2013-00346
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 = 1.6, REPEAT INR = 2.9. TESTING WAS PERFORMED WITHIN 5 MINUTES. THERAPEUTIC RANGE: 2.0 - 3.0. PT WAS MILKING FINGER AFTER THE FINGERSTICK; REPEATED FINGERSTICK ON THE SAME FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190715 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 304244

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| ORAL ANTICOAGULANTS E.G.: COUMADIN