BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2393709 · Received January 2, 2012

    Report

    Report Number
    2050012-2011-08612
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 1, 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

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ISSUE WAS RESOLVED AFTER THE FSE REPLACED THE ISE PREAMP BOARD AND DRAIN VALVE ASSEMBLY. AN ADDITIONAL MEDICAL DEVICE REPORT WAS FILED BASED ON THE SAME COMPLAINT AS MEDWATCH #2050012-2011-08613, BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4). (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED FALSELY LOW SODIUM (NA) RESULTS. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY; HOWEVER, WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED AFTER THE SYSTEM WAS RECALIBRATED, AND THE REPORTS WERE AMENDED. THEREFORE, THERE WAS NO AFFECT TO PATIENT TREATMENT. THE DIFFERENCES IN RESULTS FOR ALL OF THE AMENDED SAMPLES WERE WITHIN THE PRECISION CLAIMS OF THE ASSAY. THE CUSTOMER TECHNICAL SPECIALIST (CTS) SCHEDULED A SERVICE VISIT. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE ISE (ION SELECTIVE ELECTRODE) PREAMP BOARD AND THE DRAIN VALVE ASSEMBLY, AND CONFIRMED THAT THE ISE HEALTH CHECK TESTING PASSED SPECIFICATIONS. FINALLY, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE TROUBLESHOOTING EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1