BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2180489 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03319
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) DIRECTED THE CUSTOMER TO TRY TIGHTENING THE BOLT WHERE LIQUID WAS FLOWING FROM BUT LEAKING INCREASED. CTS THEN DIRECTED THE CUSTOMER TO TURN OFF THE DI WATER VALVE AND PLACE THE INSTRUMENT IN A STOPPED STATE. A SERVICE REQUEST WAS GENERATED BY CTS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPLACED THE MC MANIFOLD PLUG USING CUSTOMER STOCK. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THERE WAS A LEAK UNDER THE MODULAR CHEMISTRY (MC) SIDE OF THE REAGENT COMPARTMENT IN THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1