BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1883304 · Received October 22, 2010

    Report

    Report Number
    2027969-2010-01776
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 1.6, 1.9, LAB: 10.0. LAB DRAW DONE WITHIN ONE HOUR OF INRATIO TESTING. PT WAS BLEEDING FROM NOSE TO PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235793

    Patients

    Seq Age Sex Outcome Treatment
    1 Other