BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1881298 · Received October 18, 2010

    Report

    Report Number
    2027969-2010-01754
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: DATE: (B)(6) 2010, INR: 5.9; DATE: (B)(6) 2010, INR: 2.3; DATE: (B)(6) 2010, INR: 6.3; DATE: (B)(6) 2010, INR: 2.6 (NEW STRIP LOT #235737). PT HAS BEEN TESTING WITH METER FOR 5 YEARS. PREVIOUS RESULTS WERE BETWEEN 2.5-3.2 INR. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233029

    Patients

    Seq Age Sex Outcome Treatment
    1 NI