BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2192375 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-04236
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) RESEATED THE TUBING ON THE NO FOAM BOTTLE. THE FSE CONFIRMED THERE WAS NO OTHER LEAK. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED A LEAK FROM NO FOAM BOTTLE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE FLUID WAS LEAKING DOWN ONTO THE HYDRO DRIP TRAY AND ONTO THE LABORATORY FLOOR. THE CUSTOMER STATED THAT THE FLOOR WAS VERY SLIPPERY. THE CUSTOMER COULD NOT TELL THE SOURCE OF THE LEAK. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT, AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1