BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2090952 · Received May 3, 2011

    Report

    Report Number
    2027969-2011-00978
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 29, 2010
    Report Date
    May 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. PT SELF TESTER REPORTS THAT SHE HAS BEEN GETTING THE SAME RESULTS FOR THE PAST THREE WEEKS. CALLER ALSO REPORTS THAT SHE HAS BEEN EATING A LOT OF SALAD AND SHE HAS BRUISING ON HER ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 246050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other