BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2654941 · Received July 11, 2012

    Report

    Report Number
    2027969-2012-01049
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Date of Event
    June 12, 2012
    Report Date
    July 11, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN HOUSE TESTING OF CARDIAC PROFILER W49599 WITH CAL J AND CAL H RESULTED IN ALL VALUES IN THE 1 SD RANGE. NO FALSE NEGATIVE RESULT WAS OBSERVED. ALL RESULTS OF THE RETAIN TESTING MET THE RELEASE REQUIREMENT. ALL DATA POINTS WITH CAL J AND CAL H WERE WITHIN THE MANUFACTURING 1SD RANGE. AS OF (B)(4) 2012, THIS IS THE ONLY COMPLAINT AGAINST DEVICE LOT 49599. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE TNI RESULTS. RESULTS AS FOLLOWS: CUSTOMER CONDUCTED A PARALLEL DATA STUDY WITH TRIAGE AND EXL. THE PATIENT WAS TREATED BASED ON THE RESULT FROM THE EXL. TRIAGE RESULTS WERE OBTAINED IN THE BACKGROUND AND THERE WAS NO DIRECT IMPACT TO THE PATIENT. PATIENT WAS ADMITTED FOR INTERMEDIATE CORONARY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97100CP W49599B

    Patients

    Seq Age Sex Outcome Treatment
    1