BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2356036 · Received November 29, 2011

    Report

    Report Number
    2027969-2011-02428
    Event Type
    Injury
    Date Received
    November 29, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUES WITH CUSTOMER'S TECHNIQUE WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO UNEXPECTED INR RESULTS OR ERRORS IN TESTING. QC ERRORS ARE DESIGNED TO BE A FAILSAFE ERROR TO PREVENT THE REPORTING OF ERRONEOUS RESULTS. THESE CAN BE CAUSED MULTIPLE ISSUES, INCLUDING IMPROPER STORAGE, TECHNIQUE ISSUES, SAMPLE INTERFERENCE, ETC. A 75 TOTAL COMPLAINTS HAVE BEEN REPORTED FOR LOT# 251117 YIELDING A COMPLAINT RATE OF 0.026#. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF 0.1%, CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: NURSE REPORTED QC2H ERROR TWICE FROM A SINGLE PT USING ONE METER OVER ONE STRIP LOT. PT HAS SEVERAL BRUISES. PT WAS RECENTLY HOSPITALIZED FOR A-FIB AND MI; WAS DISCHARGED (B)(6) 2011. PT ON COUMADIN THERAPY RECENTLY SINCE HOSPITALIZATION. CALLER REPORTS THAT THE PT'S HANDS WERE NOT WARMED PRIOR TO FINGER STICK. AND THERE WAS SOME MILKING OF THE FINGER TO OBTAIN BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other