BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3840025 · Received May 30, 2014

    Report

    Report Number
    2050012-2014-00280
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 DISCOVERED THAT THE COLLAR WASTE VALVE ON THE MODULAR CHEMISTRY (MC) PROBE WAS FAILING INTERMITTENTLY, CAUSING WASH SOLUTION TO LEAK FROM THE PROBE ONTO THE SAMPLE TUBES, ION SELECTIVE ELECTRODES (ISE), AND MODULAR CHEMISTRIES. THE FSE REPLACED THE MC SOLENOID VALVE TO RESOLVE THE ISSUE AND NO FURTHER LEAKS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK FROM THE MODULAR CHEMISTRY (MC) PROBE OF THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS RESULTS WERE NOT 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
    318890 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1