BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3113137 · Received May 9, 2013

    Report

    Report Number
    2027969-2013-00378
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER ALLEGING DISCREPANT RESULTS. INRATIO 5.8, REPEAT 3.3, REPEAT 4.9. TIME BETWEEN TESTS FIVE MINUTES. PATIENT'S THERAPEUTIC RANGE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204737 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 299626

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| THYROID