BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 3895817 · Received June 26, 2014

    Report

    Report Number
    2050012-2014-00292
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE LEAK FROM REAGENT PROBE A IS ATTRIBUTED TO THE COLLAR WASH VALVE. THE FSE REPLACED THE COLLAR WASH VALVE TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF THE REAGENT PROBES OF THE UNICEL DXC 800 SYNCHRON SYSTEM WAS NOT VACUUMING AND LEAKED FLUID ONTO THE COVER WELL OF THE INSTRUMENT. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE PROBES WAS LEAKING. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. THE CUSTOMER DISCOVERED THE LEAK DURING MAINTENANCE AND STATED THAT THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES FOR THIS EVENT. THE CUSTOMER STATED THAT CALIBRATION PASSED AND QUALITY CONTROL (QC) RESULTS WERE WITHIN THE LABORATORY'S SPECIFICATION. THE CUSTOMER REPORTED THAT NO ERRONEOUS RESULTS HAVE BEEN GENERATED AND THEREFORE 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
    374875 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1