BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3203207 · Received July 2, 2013

    Report

    Report Number
    2050012-2013-00434
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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 CONFIRMED A LEAK FROM REAGENT PROBE A. THE FSE DETERMINED THAT THE LEAK WAS CAUSED BY A DEFECTIVE PROBE A COLLAR WASH VALVE AND PROCEEDED TO REPLACE THE VALVE. NO FURTHER LEAKS OR ERRORS WERE OBSERVED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE COLLAR WASH VALVE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING LIQUID ON THE DRIP TRAY BELOW THE REAGENT PROBES AND ON THE CC (CARTRIDGE CHEMISTRY) REACTION WHEEL COVER OF THE UNICEL DXC 800 SYNCHRON SYSTEM WHILE PERFORMING MAINTENANCE. THE CUSTOMER WAS UNABLE TO HOME THE INSTRUMENT AND THE INSTRUMENT GENERATED "CC REACTION HEATER COMMUNICATION" AND "CC REACTION SUBSYSTEM" ERROR MESSAGES. A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND THE CUSTOMER REPORTED OBSERVING AN ACTIVE LEAK FROM THE REAGENT PROBES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS ON THE DAY OF THE EVENT WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301263 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1