BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL KIT (25T)

    MDR report key: 3182574 · Received June 14, 2013

    Report

    Report Number
    2027969-2013-00480
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT HIGH TROPONIN (TNI) RESULTS. RESULTS AS FOLLOWS: NO PT INFO WAS PROVIDED. THE FOLLOWING CUT OFF'S WERE USED: TRIAGE: CKMB: 0.0-5.4 NORMAL, >5.4 ABNORMAL; MYO: 0.0-107 NORMAL, >107 ABNORMAL; TNI: 0.00-0.40 NORMAL, >0.40 ABNORMAL. ACCESS 2: AMI CUT OFF: <0.5 NG/ML, UPPER REFERENCE LIMIT: 0.04 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272158 TRIAGE CARDIAC PANEL KIT (25T) CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. BS97000HS 52798

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR