BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 1980436 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00395
    Date Received
    February 7, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER LEFT OFF TUBING FROM WASTE EXIT SUMP PRIOR TO CONTACTING CUSTOMER TECHNICAL SUPPORT (CTS). CTS ASSISTED THE CUSTOMER TROUBLESHOOT THE INSTRUMENT. THE CUSTOMER STOPPED THE DXC AND FLUID LEAKED FROM THE WASTE EXIT SUMP. THE CUSTOMER CLEANED THE SPILL AND THE SUMPS DRAINED PROPERLY. SERVICE WAS NOT DISPATCHED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO WASTE EXIT SUMP ERRORS AND DRAINED WASTE EXIT SUMPS ERRORS. NO AFFECT TO ANY PERSONNEL OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1