BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 1864551 · Received October 4, 2010

    Report

    Report Number
    2027969-2010-01645
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTS A FALSE POSITIVE TNI USING THE TRIAGE CARDIAC PROFILER KIT. THE ADMITTING DIAGNOSIS RULED OUT MI, PNEUMONIA, AND AAA POST-REPAIR. CUSTOMER REPORTED THAT THE REFERENCE RANGES FOR TNI ON THE TRIAGE CARDIAC TEST AND THE ECI TNI TEST ARE THE SAME: NORMAL = 0.00 - 0.12 NG/ML, ABNORMAL = >0.12 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97100CP W46643B

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR