BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB 25 TEST KIT

    MDR report key: 2000638 · Received February 2, 2011

    Report

    Report Number
    2027969-2011-00237
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE TROPONIN (TNI) RESULTS ON ONE PT USING THE TRIAGE PROFILER SOB 25 TEST KIT. CUSTOMER IS USING THE FOLLOWING CUT OFF'S: TRIAGE: 0.05, CENTAUR: <0.1 NG/ML, ROCHE COBAS: <0.03, VIDAS: <0.01 UG/L. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB 25 TEST KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97300 W47520B

    Patients

    Seq Age Sex Outcome Treatment
    1