BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2321761 · Received October 6, 2011

    Report

    Report Number
    2027969-2011-02086
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    August 25, 2011
    Report Date
    October 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STRIP LOT 232887 HAS EXPIRED ON THE LAST DAY OF JUNE 2011. STRIP LOT USED WERE EXPIRED. NO TRENDING IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 1.1, RETEST INRATIO: 2.1. PATIENT'S TARGET THERAPEUTIC RANGE IS 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. 100139 232887

    Patients

    Seq Age Sex Outcome Treatment
    1