BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1984348 · Received February 10, 2011

    Report

    Report Number
    2050012-2011-00421
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TRIED TO STOP AND RE-HOME THE INSTRUMENT, BUT DID NOT RESOLVE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) HAD THE CUSTOMER VERIFY EXIT WASTE SUMP AND DRAIN TUBE. THE FSE ALSO HAD THE CUSTOMER PRIME REPEATEDLY TO TEST THE SYSTEM. PROBLEM COULD NOT BE REPRODUCED. THE FSE WAS NOT DISPATCHED FOR THIS EVENT AND NO FURTHER ISSUES OCCURRED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE HYDROPNEUMATIC (HYDRO) AREA WAS LEAKING BY THE WASTE EXIT SUMP OF THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER, WHICH WAS FULL. THE CUSTOMER RECEIVED MODULAR CHEMISTRY (MC) PROBE AND LEVEL SENSE ERROR MESSAGES BEFORE GETTING THE HYDRO ERROR MESSAGE. THE CUSTOMER STATED THAT THE FLUID LOOKED CLEAR, BUT THERE WAS FOAM ON THE TOP OF THE CANISTER AND THE SOURCE OF THE LEAK COULD NOT BE DETERMINED. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1