BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2081322 · Received April 28, 2011

    Report

    Report Number
    2027969-2011-00946
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE AND FALSE POSITIVE TROPONIN (TNI) RESULTS. THE FOLLOWING TNI CUT OFF'S WERE USED: TRIAGE: GREATER THAN OR EQUAL TO 0.06 ABNORMAL, GREATER THAN OR EQUAL TO 0.40 C/W AMI. ACCESS II >0.06 ABNORMAL, >0.09 CRITICAL.

    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 W48360B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other