BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, TRIAGE, CARDIAC TNI / CKMB

    MDR report key: 3136472 · Received May 20, 2013

    Report

    Report Number
    2027969-2013-00410
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT HIGH TNI WAS OBSERVED WITH IN-HOUSE TESTING OF COMPLAINT LOT W53465. ALL REPS OF TESTING YIELDED TNI RESULTS <0.05NG/ML, AS EXPECTED. NO SAMPLE WAS RETURNED FOR TESTING. UNABLE TO DETERMINE ROOT CAUSE OF CUSTOMERS COMPLAINT. SAMPLE INTERFERENCE CANNOT BE RULED OUT. AS OF (B)(4) 2013 THERE ARE TWO TOTAL COMPLAINTS AGAINST DEVICE LOT W53465. THE OTHER COMPLAINT IS FROM THE SAME CUSTOMER. PRODUCT DEFICIENCY NOT ESTABLISHED; CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS. RESULTS AS FOLLOWS: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. PATIENT WAS REFERRED TO A CARDIOLOGIST. HIGHER RESULTS WERE REPORTED. EXPERIENCED TECHNICIAN PERFORMED TESTS. QC AND QCD PASSED, AS EXPECTED. EDTA WB, FULL-DRAW. VISUAL INSPECTION OF SPECIMEN: OK, NOTHING UNUSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223345 KIT, TRIAGE, CARDIAC TNI / CKMB CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97022HS W53465RB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR