BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1780866 · Received July 27, 2010

    Report

    Report Number
    2027969-2010-01053
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT'S THERAPEUTIC RANGE IS 2-3. PATIENT'S WARFARIN DOSE WAS CHANGED ON (B)(6) 2010 DUE TO LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 229442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other