BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2467369 · Received February 24, 2012

    Report

    Report Number
    2050012-2012-00588
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED FALSELY LOW SODIUM RESULTS FOR THREE PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND/OR ON ANOTHER DXC INSTRUMENT IN THE LABORATORY, AND THOSE RESULTS WERE REPORTED. THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE SODIUM REFERENCE ELECTRODE. THE FSE ALSO CALIBRATED THE DAC (DIGITAL-TO-ANALOG CONVERTER) BOARD. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT.

    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. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1