BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2174110 · Received July 24, 2011

    Report

    Report Number
    2050012-2011-03204
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PRIMED AND CALIBRATED THE INSTRUMENT AND QC RESULTS WERE WITHIN RANGE. THE CUSTOMER REVIEWED STATUS SCREEN, NO ISSUES WERE NOTED AND NO LEAKS. THE CUSTOMER REQUESTED A SERVICE VISIT TO CHECK OPERATION OF THE INSTRUMENT. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. FSE VERIFIED THE LEAK ISSUE AND NOTED THE WASH SOLUTION CANISTER WAS OVERFILLED. FSE REPLACED THE WASH SOLUTION CANISTER FLOAT SWITCH FSE REPLACED VALVES V12 AND V14 (BOTH ASSOCIATED WITH THE WASH SOLUTION CANISTER). FSE PRIMED THE HYDRO AND FILLED ALL CANISTERS AND NO FURTHER ISSUES OBSERVED. REPAIRS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A LIQUID LEAK OUT OF THE MIDDLE OF THE INSTRUMENT AND ONTO THE FLOOR. THE CUSTOMER STATED THE FLUID WAS A LIGHT YELLOW. CREATININE REAGENT CONTAINER WAS CHECKED FOR DAMAGES AND NONE WERE NOTED. 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 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1