BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2342609 · Received November 18, 2011

    Report

    Report Number
    2050012-2011-07626
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 19, 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

    ADDITIONAL MDRS HAVE BEEN FILED BASED ON THE SAME SET OF EVENTS: MEDWATCH #2050012-2011-07627 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)). MEDWATCH #2050012-2011-07628 (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 ERRONEOUS TRIGLYCERIDE AND MAGNESIUM RESULTS. CUSTOMER REFUSED TO TROUBLESHOOT THE INSTRUMENT OR PROVIDE INFORMATION UNTIL ONSITE SERVICE WAS PROVIDED. ON THE SAME DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE REAGENT SYRINGE DRIVE ASSEMBLY. AFTER RUNNING 40 REPETITIONS OF HIGH AND LOW QUALITY CONTROLS FOR A PRECISION RUN, ALL RESULTS PASSED SPECIFICATIONS. THE FSE WAS NOT ABLE TO DETERMINE THE ROOT CAUSE, BUT IT APPEARED TO BE A HARDWARE MALFUNCTION. CUSTOMER STATED THAT PATIENT TREATMENT WAS NOT AFFECTED. THE FSE RETURNED ON (B)(6) 11 AND REPORTED THAT THE INSTRUMENT WAS GENERATING SUPPRESSED TRIGLYCERIDE RESULTS. AFTER REPLACING BOTH THE REAGENT PROBES AND THE WASH COLLARS, THE FSE FOUND THAT 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