BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOTAL 5 CONTROL L1

    MDR report key: 6038710 · Received October 18, 2016

    Report

    Report Number
    2027969-2016-00655
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 20, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR IS BEING FILED DUE TO FIELD ACTION REF-2027969-10/12/16-004-C. 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, (B)(4), WAS INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER ATTEMPTED TO RUN THE TOTAL 5 CONTROL LEVEL 1 AT 2 STDEV WITH A CK-MB RESULT OUTSIDE OF THE EXPECTED RANGE LOW AT 3.6 NG/ML (2 STDEV: 3.7-6.6 NG/ML) AND A TNI RESULT WITHIN THE EXPECTED RANGE AT 0.33 NG/ML (2 STDEV: 0.32-0.62 NG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689897 TRIAGE TOTAL 5 CONTROL L1 MULTI-ANALYTE CONTROLS JJY 88753 C3233A

    Patients

    Seq Age Sex Outcome Treatment
    1 CARDIAC TRIPLE MARKER, PN 97000HS, LOT# W61164B| TRIAGE METERPRO DOMESTIC KIT, PN 55070, SN (B)(4)