BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3122355 · Received May 21, 2013

    Report

    Report Number
    2050012-2013-00319
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED LIQUID SPLASHING FROM THE CC (CARTRIDGE CHEMISTRY) COLLAR WASH WHEN THE SYSTEM WAS PRIMING. THE FSE REPLACED THE CC SAMPLE PROBE COLLAR WASH TO RESOLVE THE LEAK. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND NO FURTHER LEAKS WERE OBSERVED. FAILURE MODE IS ATTRIBUTED TO THE CC COLLAR WASH. RESULTS: CC SAMPLE PROBE COLLAR WASH. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A CONTAINED CC (CARTRIDGE CHEMISTRY) SAMPLE PROBE LEAK INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER DISCOVERED APPROXIMATELY 20 ML OF CLEAR FLUID ON THE REACTION WHEEL COVER IN THE WELL AREA. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE WEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223654 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1