BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE BIOSITE TRIAGE METER/CARDIAC MARKER CARTRIDGE

    MDR report key: 2565397 · Received May 3, 2012

    Report

    Report Number
    MW5025312
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ALERE BIOSITE
    Product Code
    MMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CHEST PAIN, HYPERTENSIVE EVENT PRESENTED TO THE EMERGENCY DEPARTMENT. INITIAL SET OF CARDIAC MARKERS (CTNI, CKMB, MYOG) DONE USING POINT OF CARE TESTING ALERE BIOSITE TRIAGE CARDIAC CARTRIDGE. RESULTS INDICATED NORMAL INTERPRETATION. SUBSEQUENT CTNI DONE IN MAIN CLINICAL LAB ON SIEMENS VISTA INSTRUMENTATION INDICATED EXTREMELY HIGH LEVELS OF CTNI. ORIGINAL POC SAMPLE RUN ON ALERE BIOSITE TRIAGE CARDIAC CARTRIDGE WAS RE-RUN ON MAIN LAB VISTA INSTRUMENTATION AND INDICATED A POSITIVE LEVEL OF CTNI WAS DETECTED. SENSITIVITY/SPECIFICITY OF ALERE BIOSITE CARDIAC MARKER LOT #49752, INSTRUMENT S/N (B)(4) IS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALERE BIOSITE TRIAGE METER/CARDIAC MARKER CARTRIDGE TRIAGE CARDIAC MARKER - CTNI, CKMB, MYOGLOBIN MMI ALERE BIOSITE CARDIAC MARKER PROF
    2 ALERE BIOSITE TRIAGE METER/CARDIAC MARKER CARTRIDGE TRIAGE CARDIAC MARKER - CTNI, CKMB, MYOGLOBIN JHX ALERE BIOSITE 49752

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization