BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2213758 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04568
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) FOUND NO FOAM LEAKED AT THE RIGHT SINGLE FITTING AND THE TUBING AT THAT END WAS LOOSE, WHICH DRIPPED NO FOAM. FSE REPLACED THE TUBING, WHICH RESOLVED THE LEAK ISSUE. FSE CLEANED: THE NO FOAM REAGENT SPILL ON THE HYDRO CHASSIS. THE FLOOR AROUND THE INSTRUMENT. THE INSTRUMENT BOTTOM CHASSIS. FSE LOADED NEW NO FOAM REAGENT AND PRIMED THE SYSTEM. THE CUSTOMER PERFORMED DAILY MAINTENANCE WITH NO ISSUES WERE NOTED. TESTED RUN WITH CONTROLS, WHICH WERE ACCEPTABLE AND NO ISSUES WERE NOTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT INSTRUMENT LEAK ON THE UNICEL DXC 600P SYNCHRON CHEMISTRY ANALYZER THE CUSTOMER COVERED AND CLEANED THE SPILL WITH TOWELS. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1