BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1890360 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01169
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND SEVERAL REAGENT CARTRIDGES WITH BLUE LIQUID ON THE SURFACE. FSE WAS UNABLE TO DETERMINE WHERE THE BLUE LIQUID ORIGINATED FROM. FSE CLEANED SEVERAL REAGENT CARTRIDGES. THE CUSTOMER RAN QC. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO WET REAGENT CARTRIDGES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1