BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1911438 · Received November 17, 2010

    Report

    Report Number
    2027969-2010-01981
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010; INRATIO: 1.1; RETEST INRATIO: 2.9; UNKNOWN METER: 2.8. RESULTS ALL DONE WITHIN 1 HOUR. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1