BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1914101 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02030
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER. DATE: UNK, INRATIO: 1.5; DATE: UNK, INRATIO: 1.5. PT HAD 1.5 INR ON METER ON TWO RECENT OCCASIONS. COUMADIN DOSAGE WAS CHANGED AND PT EXPERIENCED NOSEBLEEDS, BRUISING, AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200457 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other