BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2176393 · Received July 25, 2011

    Report

    Report Number
    2050012-2011-03205
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 A BEC FIELD SERVICE ENGINEER (FSE) FOUND A POOR SIGNAL FROM THE WASH SOLUTION CANISTER FLOAT SWITCH CAUSING THE CANISTER TO OVERFILL AND LEAK OUT REGULATOR. FSE REPLACED THE FLOAT SWITCH FOR WASH SOLUTION AND VERIFIED OPERATION. REPAIR VERIFIED PER ESTABLISHED PROCEDURES. BEC INTERNAL NOTIFICATION NUMBER IS (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A LEAK FROM THE 10 PSI AND AIR PRESSURE WAS RUNNING LOW. ON (B)(6) 2011, THE CUSTOMER STATED THEY WERE RECEIVING AIR PRESSURE HIGH ERROR AND CUVETTES RAILING WATER BLANK. CUSTOMER FOUND WASH SOLUTION EMPTY AND TRIED FILLING CANISTERS IN PRIME AND FOAMY LIQUID SPEWED OUT OF THE 10 PSI REGULATOR. 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