BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 2060406 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01175
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER WITH WASH CONCENTRATE ERRORS, CUSTOMER CHECKED THE HYDRO DRAWER AND THE CUSTOMER STATES THAT THE TOP OF THE LID IS CRUSTY WITH LEAKED WASH CONCENTRATE FLUID. A BCI FIELD SERVICE ENGINEER REPLACED THE WASH CANISTER ASSEMBLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FALSE WASH CONCENTRATE LOW ERRORSN. NO 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