BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2001283 · Received February 24, 2011

    Report

    Report Number
    2050012-2011-00559
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER ON (B)(4) 2011. DURING TROUBLESHOOTING IT WAS DISCOVERED THAN THE VACUUM LINE FROM THE ISE DRAIN WAS LOOSE. THE CUSTOMER RECONNECTED THE LINE AND INSPECTED FOR LEAKS. NO LEAK WAS OBSERVED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAKAGE ON UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER STATED THE INSTRUMENT WAS LEAKING ONTO MODULAR CHEMISTRY SIDE DRIP TRAY AFTER CHANGING CO2 ALKALINE BUFFER. NO OPERATOR EXPOSURE WAS NOTED. BCI CUSTOMER TECHNICAL SUPPORT RECOMMENDED REVIEW OF WASH CONCENTRATE MSDS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1