BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2626935 · Received June 24, 2012

    Report

    Report Number
    2050012-2012-01333
    Event Type
    Malfunction
    Date Received
    June 24, 2012
    Date of Event
    May 30, 2012
    Report Date
    May 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON SYSTEM (DXC 600) GAVE K (POTASSIUM) B/B (BACK TO BACK) AND RANGE ERRORS AFTER PERFORMING ION SELECTIVE ELECTRODE (ISE) SERVICE PROCEDURES SUCH AS REPLACING THE CHLORIDE TIP. CUSTOMER REPORTED THAT THE ISSUE HAS BEEN ONGOING AND HAS OCCURRED BOTH BEFORE AND AFTER REPLACING THE K TIP LAST MONTH. CUSTOMER REPORTED THAT THE DXC 600 GENERATED AN ERRONEOUS RESULT ON ONE PATIENT SAMPLE. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS NOT 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) CLEANED THE FLOWCELL AND THE CARBON BRIDGE. THE FSE ALSO REPLACED THE K ELECTRODE TIP AND BODY. THE FSE VERIFIED PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1