BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2522112 · Received April 8, 2012

    Report

    Report Number
    2050012-2012-00884
    Event Type
    Malfunction
    Date Received
    April 8, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT WATER WAS LEAKING OUT OF THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. CUSTOMER REPORTED THAT THERE WAS A SMALL AMOUNT OF WATER DRIPPING FROM THE BACK OF THE ANALYZER AND RUNNING ALONG THE CHASSIS. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND WATER WAS COMING OUT OF THE TOP OF THE MODULAR CHEMISTRY (MC) MANIFOLD. THE FSE REPLACED THE PLASTIC NUT AND THE MC MANIFOLD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1