BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2490762 · Received March 7, 2012

    Report

    Report Number
    2027969-2012-00271
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 12, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT SAMPLES WERE RETURNED FOR TESTING. PRODUCT POSITIVE CONTROL, CALIBRATOR H (CAL H), AND 2 WHOLE BLOOD (EDTA) DONORS FOR OBSERVATIONS OF TNI RECOVERY. NO FALSE NEGATIVE RESULTS WERE OBSERVED WITH CAL H AND NO FALSE POSITIVES WERE OBSERVED WITH NORMAL WHOLE BLOOD DONORS. PRODUCT SUPPORT WAS UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCES THAT ARE KNOWN TO AFFECT ANALYTE RECOVERY. (B)(4). THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (POINT-OF-CARE COORDINATOR) REPORTED POTENTIAL FALSE NEGATIVE TROPONIN (TNI) ON THE TRIAGE CARDIAC PROFILER VERSUS THE SIEMENS EXL. BLOOD SAMPLE WAS RUN AT 14:55 ON THE SIEMENS EXL. PT WAS ADMITTED. PT ALSO HAD A GLUCOSE OF >700. CALLER DID NOT REPORT THAT PT HAD AN MI. STAFF DECIDED TO RUN THE SAMPLE ON THE TRIAGE METER. AT 16:37, A SECOND SAMPLE CAME IN AND THEY DECIDED TO RUN THAT ON A DIFFERENT TRIAGE METER. CALLER MENTIONED THAT ALL SUBSEQUENT DRAWS WERE ONLY RUN ON THE SIEMENS AND THEY WERE ALL REPORTED AS NEGATIVE. CALLER SAID THE QCD ALL PASSED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER PANEL MMI ALERE SAN DIEGO, INC. 97100CP W49589B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI