BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2932365 · Received January 22, 2013

    Report

    Report Number
    2027969-2013-00071
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ALLEGING DISCREPANT READINGS ON INRATIO METER. INITIAL: 4.1, REPEAT: 1.9, 2.6, LAB: 2.6. ALL RESULTS OBTAINED WITHIN A TWO HOUR PERIOD. PT'S THERAPEUTIC RANGE 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31538 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 294977

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN