BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER

    MDR report key: 1213197 · Received October 22, 2008

    Report

    Report Number
    2027969-2008-00029
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION PENDING.

    Description of Event or Problem · 1

    FALSE NEGATIVE TROPONIN (TNI) ON TRIAGE CARDIO PROFILER (<0.05 NG/ML, < 0.05 NG/ML) AS COMPARED WITH BECKMAN ACCESS (4.40 NG/ML, 4.06 NG/ML); 2 DRAWS FROM SAME PT 2 HOURS APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97100CP W43203B

    Patients

    Seq Age Sex Outcome Treatment
    1