BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2221688 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01817
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 0.9, LAB: 0.9. METER AND LAB TESTS WERE DONE WITHIN ONE HOUR. PATIENT WAS HOSPITALIZED UNTIL YESTERDAY ((B)(6) 2011) AND WAS BEING TREATED WITH (B)(6) UNTIL THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239278

    Patients

    Seq Age Sex Outcome Treatment
    1