BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 6917817 · Received October 5, 2017

    Report

    Report Number
    2027969-2017-00152
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 11, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W62717RB. NO DISCREPANT RESULTS WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THIS EVENT IS BEING REPORTED AS PART NUMBER 97000HSEU IS SAME/SIMILAR TO 510K # K030286.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING ON ONE PATIENT: ON (B)(6) 2017, AN EDTA BLOOD SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED USING THE TRIAGE CARDIAC TRIPLE MARKER PANEL. THE TRIAGE CARDIAC TRIPLE MARKER PANEL PRODUCED AN ABNORMAL TNI RESULT OF 0.06 NG/ML. THE TEST WAS REPEATED AND A SECOND TRIAGE CARDIAC TRIPLE MARKER PANEL PRODUCED A NORMAL TNI RESULT OF <0.05 NG/ML. A NEW SAMPLE WAS THEN COLLECTED FROM THE PATIENT AND TESTED USING AN ELECTROCHEMILUMINESCENCE METHODOLOGY. THE ELECTROCHEMILUMINESCENCE METHODOLOGY PRODUCED A NORMAL TNI RESULT OF 0.16 NG/ML. THE FACILITY'S NORMAL TNI CUTOFF FOR THE TRIAGE CARDIAC TRIPLE MARKER PANEL WAS REPORTED TO BE <0.05 NG/ML. THE FACILITY'S NORMAL TNI CUTOFF FOR THE ELECTROCHEMILUMINESCENCE METHODOLOGY WAS REPORTED TO BE 0.16 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697959 TRIAGE CARDIAC TRIPLE MARKER PANEL IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ALERE SAN DIEGO, INC. 97000HSEU W62717RB

    Patients

    Seq Age Sex Outcome Treatment
    1