BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER

    MDR report key: 1070763 · Received July 3, 2008

    Report

    Report Number
    2027969-2008-00006
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO ER WITH CHEST PAIN. INITIAL BLOOD DRAW TESTED WITH TRIAGE CARDIO PROFILER TEST ELEVATED RESULTS OF CKMB 1.3, TROPONIN I (TNI) 0.13; RETEST OF SAME SAMPLE GAVE NORMAL LEVELS OF CKMB <1.0; TNI <0.05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97100CP W42275

    Patients

    Seq Age Sex Outcome Treatment
    1