BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1800691 · Received August 4, 2010

    Report

    Report Number
    2027969-2010-01132
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL VS. ACCESS. ONE SAMPLE WAS REPEATED USING A DIFFERENT METER AND GAVE DIFFERENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W47019

    Patients

    Seq Age Sex Outcome Treatment
    1