BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2342611 · Received November 18, 2011

    Report

    Report Number
    2050012-2011-07628
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 27, 2011
    Report Date
    October 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE IS UNKNOWN; HOWEVER, THE ISSUE WAS RESOLVED AFTER THE FIELD SERVICE ENGINEER PERFORMED THE SERVICES. ADDITIONAL MDRS HAVE BEEN FILED BASED ON THE SAME SET OF EVENTS: MEDWATCH #2050012-2011-07626 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)). MEDWATCH #2050012-2011-07627 (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 ERRATIC QUALITY CONTROL RESULTS FOR TRIGLYCERIDE (TG) AND MAGNESIUM (MG) ON TWO INSTRUMENTS. THIS REPORT IS BEING FILED ON ONE OF THE INSTRUMENTS, SERIAL NUMBER (B)(4). PLEASE NOTE THAT ANOTHER REPORT WAS FILED FOR THE OTHER INSTRUMENT, SERIAL NUMBER (B)(4), AS MEDWATCH #2050012-2011-07627 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)). CUSTOMER STATED THAT TG VALUES WERE >500 MILLIGRAMS PER DECILITER (MG/DL), AND UPON REPEAT WAS <120 MG/DL. ALSO, THE MG VALUES WERE >5.0 MG/DL, AND UPON REPEAT WAS 2.0 MG/DL. THE CUSTOMER TECHNICAL SPECIALIST (CTS) SUGGESTED TO CUSTOMER THAT THE ROOT CAUSE MIGHT BE THE LABORATORY'S DEIONIZED WATER SYSTEM, AS THE TWO INSTRUMENTS SHARE THE SAME WATER SYSTEM. CUSTOMER EXPLAINED THAT SERVICE ON THE WATER SYSTEM WAS DUE, AND THAT CUSTOMER WOULD HAVE THE TANKS CHANGED, ALONG WITH THE .2 MICRON FILTERS. CUSTOMER SUSPECTS THAT THESE HAVE NOT BEEN CHANGED FOR OVER A YEAR. CUSTOMER REQUESTED SERVICE TO ENSURE THAT THE ISSUES WOULD BE RESOLVED. CUSTOMER STATED THAT PATIENT TREATMENT WAS NOT AFFECTED. ON THE SAME DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND DETERMINED THAT THE INSTRUMENT WAS GENERATING SUPPRESSED TRIGLYCERIDE RESULTS. AFTER REPLACING BOTH THE REAGENT PROBES AND THE WASH COLLARS, THE FSE FOUND THAT THE CARTRIDGE CHEMISTRY MIXER WASH STATION WAS NOT PROPERLY FUNCTIONING. THE FSE THEN REPLACED ITS VALVE, AFTER WHICH INSTRUMENT PERFORMANCE WAS VERIFIED TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE ISSUE. THE FSE THEN VERIFIED THAT THE PRECISION RUN AND QUALITY CONTROLS WERE ACCEPTABLE AND WITHIN RANGE.

    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