BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1982597 · Received January 12, 2011

    Report

    Report Number
    2027969-2011-00082
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT RESULTS USING THE INRATIO METER. PT SELF TESTER GOT 3.3, 3.8, AND 2.8 BEFORE CALLING IN TO TECHNICAL SERVICES. ALL ON SEPARATE FINGERS. HE WAS PRETTY SURE IT WAS A TECHNIQUE PROBLEM. HAD TROUBLE FILLING CAP TUBES WITH FIRST DROP ON EACH TEST, SO HE SWITCHED TO TESTING DIRECTLY AND GOT RESULTS WITH THE 2ND OR 3RD DROP. RETESTED OVER THE PHONE DIRECT FROM FINGERTIP. FIRST DROP ALWAYS MISSED THE SAMPLE WELL. SOMETIMES IT WAS THE 3RD OR 4TH DROP THAT WENT IN. GOT 1.9 TWICE WHILE ON THE PHONE. TESTED AGAIN AND 1ST DROP HIT; THIS TIME GOT 3.3. CUSTOMER WAS INITIALLY REQUESTING RE-TRAINING, BUT DECIDED TO WAIT. PT FELT COMFORTABLE WITH THE 3.3 RESULT (TECHNIQUE WAS BETTER THAT TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1