BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2192158 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-03892
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER REPLACED LINES 142, 145, &127 TO CORRECT THE WASH CONCENTRATE LEAK. BEC INTERNAL NOTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT OBSERVING YELLOW DRIED CRYSTALS ON THE BOTTOM OF THE HYDRO-PNEUMATIC DRAWER AND FLUID LEAK. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SOURCE OF THE LEAK. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1