BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2242504 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05054
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT THE WASH CONCENTRATE VALVE HAD A VERY SMALL LEAK IN THE TUBING. THE FSE CUT THE TUBING BACK AND REFIT IT ONTO THE VALVE FITTING. THE FSE PRIMED THE HYDRO AND INSTRUMENT, AND FOUND NO LEAKS. (B)(4)..

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT AUTOGLOSS WAS LEAKING ON UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER ALSO REPORTED THAT THE LINE FROM THE WASH CONCENTRATE RESERVOIR WAS ALL CRUSTED WITH DRIED SALTS. THE CUSTOMER WAS WEARING GLOVES AND LAB COAT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1