BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2318292 · Received November 1, 2011

    Report

    Report Number
    2050012-2011-06992
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SODIUM AND POTASSIUM WERE FAILING CALIBRATION ON THE UNICEL DXC 600 SYNCHRON SYSTEM (DXC 600). BEC CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER TO PERFORM THE MODULAR CHEMISTRY LEVEL SENSE TEST USING BEC BLEACH. THE CTS ADVISED THE CUSTOMER TO PRIME THE ION SELECTIVE ELECTRODE TEN (10) TIMES AND CALIBRATE USING SERUM AND THEN AQUA CALIBRATOR. THE CTS ADVISED CUSTOMER TO RERUN PATIENT SAMPLES TO VERIFY THAT THERE WERE NO ERRONEOUS RESULTS. CUSTOMER CALLED BACK AND REPORTED THAT ALL ELECTROLYTES CALIBRATED. CUSTOMER REPORTED THAT THE DXC 600 GENERATED ERRONEOUS CO2 RESULT FOR ONE PATIENT SAMPLE. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND COULD NOT DUPLICATE THE ISSUE. THE FSE PERFORMED PREVENTIVE MAINTENANCE WHILE AT CUSTOMER'S SITE. THE FSE VERIFIED PERFORMANCE. TO DATE, CUSTOMER HAS NOT REPORTED THE ISSUE RECURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR