BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210889 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04062
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ADVISED CUSTOMER TO HAVE PROPER PROTECTIVE EQUIPMENT (PPE) ON AND USE INSTRUMENT COMMAND TO SHUTDOWN SYSTEM. A SERVICE REQUEST WAS GENERATED AND FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND FOUND MODULAR CHEMISTRY (MC) SAMPLE PROBE PLUGGED. FSE REPLACED THE PROBE AND MC TRANSDUCER AND THE ISSUE WAS RESOLVED. CALIBRATION WAS PERFORMED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE BEC INTERNAL DENTIFER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A MC (MODULAR CHEMISTRY) OBSTRUCTION DETECTION TRANSDUCER FAILURE AND UNRECOVERABLE MC OBSTRUCTION IN THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. PER CUSTOMER, THERE WERE ALSO LIQUID ON TOP OF THE INSTRUMENT MODULAR COVERS AND THE SAMPLE CAROUSEL COVER. THE CUSTOMER WAS UNABLE TO DETERMINE SOURCE OF THE LEAK OR THE TYPE OF LIQUID BUT STATED IT WAS CLEAR LIQUID, POSSIBLY WATER OR WASH SOLUTION. NO INJURY OR EXPOSURE 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