BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1819353 · Received August 25, 2010

    Report

    Report Number
    2027969-2010-01278
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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:" >7.5 AND 1.2. CUSTOMER OBTAINED >7.5 ERROR MESSAGE TWICE WHEN TESTING SAME PT. NO LAB DRAWS WERE DONE. LAST WEEK PT RESULTED IN 1.2 (NO RANGE ESTABLISHED YET). ON COUMADIN FOR ONLY APPROX 1.5 WEEKS (COUMADIN WAS STOPPED WHEN PT WAS HOSPITALIZED/ADMITTED FOR 1.5 WEEKS). PT IS NOT ON HEPARIN, LOVENOX, AMIODARONE, ABX. NO CANCER, ANEMIA, DIALYSIS, THYROID DYSFUNCTION, APS, LUPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 223042

    Patients

    Seq Age Sex Outcome Treatment
    1