BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER

    MDR report key: 2132431 · Received June 13, 2011

    Report

    Report Number
    2027969-2011-01326
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER (LAB PERSONNEL) REPORTED POTENTIAL FALSE POSITIVE TROPONIN (TNI) ON THE TRIAGE CARDIOPROFILER. PATIENT IS (B)(6) MALE WHO WENT TO THE EMERGENCY DEPARTMENT COMPLAINING ABOUT CHEST PAIN. IT IS UNKNOWN IF THE PATIENT WAS ADMITTED OR DISCHARGED OR IF AN EKG OR ANY INVASIVE PROCEDURE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER CARDIAC PANEL MARKER MMI ALERE SAN DIEGO, INC. 97100CP W48393

    Patients

    Seq Age Sex Outcome Treatment
    1 NI