BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER

    MDR report key: 2546747 · Received April 20, 2012

    Report

    Report Number
    2027969-2012-00559
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    March 25, 2012
    Report Date
    April 20, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER RER ALLEGES FALSE POSITIVE TROPONIN I (TNI) RESULT WITH METER. PT WAS ADMITTED TO ER AND WHOLE BLOOD SAMPLE WAS TESTED: (B)(6) 2012 AT 12:15 TRIAGE RESULTED TNI=0.14. ON (B)(6) 2012 SAMPLE DRAWN AT 4AM WAS SPUN TO PLASMA AND RUN AT 9:00 AM: TRIAGE TNI=1.22. VISTA TNI<0.02. CUSTOMER THEN SPUN ORIGINAL SAMPLE FROM (B)(6) 2012 DOWN TO PLASMA (21 HOURS LATER): TRIAGE TNI=1.21. VISTA TNI<0.02. DIAGNOSIS INITIALLY WAS INCREASE IN TNI - NSTEMI. CUSTOMER USES TRIAGE TNI CUTOFF OF 0.4 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97100CP W49619B

    Patients

    Seq Age Sex Outcome Treatment
    1