BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOTAL 5 CONTROL L1

    MDR report key: 6038570 · Received October 18, 2016

    Report

    Report Number
    2027969-2016-00653
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 29, 2016
    Product Code
    JJY
    PMA / PMN Number
    K072892
    Removal / Correction Number
    2027969-10/12/16-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR IS BEING FILED DUE TO FIELD ACTION (B)(4). CUSTOMER'S COMPLAINT WAS REPLICATED WITH IN-HOUSE TESTING OF THE CODE CHIP OF RETAIN LOT C3233A. CODE CHIP RANGES DID NOT MATCH EV CARD RANGES. THE MANUFACTURING RECORDS FOR THE CONTROL LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A CAPA, CAPA-(B)(4), WAS INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE SUPPORT CONSULTANT ATTEMPTED TO RUN THE TOTAL 5 CONTROL LEVEL 1 TWICE AT 2 STDEV WITH MYOGLOBIN RESULTS OUTSIDE OF THE EXPECTED RANGE HIGH AT 132 NG/ML AND 131 NG/ML (2 STDEV: 71.9-119 NG/ML). THE SUPPORT CONSULTANT INSTALLED A CODE CHIP FROM A DIFFERENT BOX OF CONTROLS WITH THE SAME LOT NUMBER AND THEN ATTEMPTED TO RUN THE TOTAL 5 CONTROL LEVEL 1 AT 3 STDEV WITH A MYOGLOBIN RESULT OUTSIDE OF THE EXPECTED RANGE HIGH AT 124 NG/ML (3 STDEV: 60.2-131 NG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689615 TRIAGE TOTAL 5 CONTROL L1 MULTI-ANALYTE CONTROLS JJY 88753 C3233A

    Patients

    Seq Age Sex Outcome Treatment
    1 CARDIAC TRIPLE MARKER, PN 97000HS, LOT# W61684B| TRIAGE METERPRO DOMESTIC KIT, PN 55070, SN (B)(4)