BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1954281 · Received December 13, 2010

    Report

    Report Number
    2027969-2010-02159
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2010; INRATIO2: 1.3; DATE: (B)(6) 2010; INRATIO2: 1.4; LAB: 3.9. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. PATIENT HAS BEEN ON LOVENOX AND COUMADIN BRIDGE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 237433

    Patients

    Seq Age Sex Outcome Treatment
    1