BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3099128 · Received May 1, 2013

    Report

    Report Number
    2027969-2013-00360
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INRATIO = 4.8; RETEST = QC?H; RETEST = 1.6. PT SELF TESTER TESTED; INRATIO = 4.8. HUSBAND RETEST PT SELF TESTER DUE TO HIGH RESULT; QC?H. HUSBAND RETESTED PT SELF TESTER ONE MORE TIME; INRATIO = 1.6. ALL TEST PERFORMED USING DIFFERENT FINGERS; TESTS WERE PERFORMED MINS APART. THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189328 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 304244

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| STABLE ON ALL OTHER MEDICATIONS| HEPARIN MAY HAVE BEEN GIVEN WITH THE GAMMAGARD| INFUSION