BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1770343 · Received July 16, 2010

    Report

    Report Number
    2027969-2010-00974
    Event Type
    Other
    Date Received
    July 16, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 7.4, LAB: 4.9. OBSERVED SOME BRUISING, BUT CANNOT CONFIRM IF DUE TO HIGH INR RESULTS; COUMADIN HELD FOR 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other