BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1811784 · Received August 23, 2010

    Report

    Report Number
    2050012-2010-00581
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THE LEAK COMING FROM THE HYDRO PNEUMATIC AREA ON THE INSTRUMENT AND SYSTEM GENERATING HIGH VACUUM PRESSURE IS LOW ERROR MESSAGE. THE CUSTOMER HAD PREVIOUSLY EXPERIENCED WATER FILTERING SYSTEM LEAK AND BELIEVED THE LEAK WAS THE SAME AND DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER TRACED THE LEAK BACK TO THE WASH CONCENTRATE REAGENT, WHICH WAS BUBBLING OUT OF THE CONTAINER AND SPLASHED HER HAND. HOTLINE ADVISED CUSTOMER TO WEAR PPE AND PROVIDE CUSTOMER WITH MSDS. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE LOOSE VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT WASH CONCENTRATE REAGENT FROM UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER SPILLED ON THE CUSTOMER HAND CAUSING SLIGHT BURN AND RASH DEVELOPMENT. THE CUSTOMER WAS SENT TO ER.

    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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1