BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO

    MDR report key: 2266577 · Received September 28, 2011

    Report

    Report Number
    2050012-2011-05778
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE ELECTROLYTE INJECTION CUP (EIC) ON THE UNICEL DXC 600 WAS OVERFLOWING. THE CUSTOMER TECHNICAL SPECIALIST ASSISTED CUSTOMER WITH TROUBLESHOOTING TO LOOK FOR CLOTS IN THE EIC. NO CLOTS WERE FOUND AND A SERVICE REQUEST WAS GENERATED. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE EIC VALVES, BUT THE LEAKING FROM THE EIC CONTINUED. THE FSE THEN FOUND THAT THE DRAIN LINE WAS CLOGGED WITH UNIDENTIFIABLE MATERIAL. THE FSE REMOVED THE CLOG AND FLUSHED THE LINE. THE FSE THEN TESTED THE ION SELECTIVE ELECTRODE CALIBRATION AND QUALITY CONTROLS OF THE INSTRUMENT TO ENSURE THAT THE SERVICE PERFORMED ON THE INSTRUMENT WAS EFFECTIVE. ALL TEST RESULTS PERFORMED BY THE FSE WERE WITHIN INSTRUMENT SPECIFICATIONS AND THE EIC OVERFLOW ISSUE WAS RESOLVED. CUSTOMER DID NOT REPORT HARM TO PATIENTS OR INSTRUMENT OPERATORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1