BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2060405 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01174
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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

    CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. CUSTOMER CONFIRMED CANISTER IS WET AT THE BOTTOM AND CANISTER IS EMPTY. SERVICE WAS NOT DISPATCHED. CUSTOMER PRIMED ALL CC AND HYDRO SUBSYSTEMS AND CHECKED CANISTERS FOR OUTSIDE WETNESS, AND FOUND NO LIQUID ON THE FLOOR. CUSTOMER TO MONITOR AND INFORM BCI IF PROBLEM CONTINUES. NO FURTHER COMPLAINT ON HYDRO LEAKING HAS BEEN FILED AS OF (B)(6) 2011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A WASTE CANNISTER LEAK. NO INJURY WAS REPORTED OR OCCURRED DUE TO THIS EVENT.

    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. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1