BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2004120 · Received February 25, 2011

    Report

    Report Number
    2027969-2011-00407
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER. STRIP LOT #241836 WAS USED ON 2/4 AND 2/5. ALL OTHER RESULTS WERE OBTAINED USING STRIP LOT #243934. PT IS BRUISING AND BLEEDING AT INJECTION SITES, AND HAS HEMORRHOIDAL BLEEDING AS WELL. PT HAS VASCULITIS AND MANY OTHER HEALTH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other