BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2746078 · Received September 14, 2012

    Report

    Report Number
    2050012-2012-01447
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED AN ERRONEOUS CREATININE RESULT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A PIECE OF 2 MM GREY PLASTIC INSIDE THE CREATININE MODULE DRAIN VALVE THE FSE REPLACED THE VALVE. THE FSE ALSO REPLACED THE MODULAR CHEMISTRIES SAMPLE PROBE AND PERFORMED REAGENT LINE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1