BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2981790 · Received February 27, 2013

    Report

    Report Number
    2050012-2013-00122
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A LEAK FROM REAGENT PROBE B OF A UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED TO THE INSTRUMENT AND WAS OBSERVED WHILE LOADING REAGENTS ONTO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE COLLAR WASH WASTE VALVE WAS NOT OPENING AS INTENDED THEREBY CAUSING THE LEAK. THE FSE REPLACED THE COLLAR WASH WASTE VALVE AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83549 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1