BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2152794 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02884
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 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
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHECKED CANISTER LIDS AND FITTINGS AND DID NOT FIND A PROBLEM. BCI CTS (CUSTOMER TECHNICAL SUPPORT) CONFIRMED THAT THE STATUS OF THE HYDROPNEUMATIC SYSTEM WAS FINE AND DIRECTED THE CUSTOMER TO MONITOR THE INSTRUMENT AND CALL BACK IF LEAKING CONTINUED. NO FURTHER CALLS WERE RECEIVED REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REPORTING A LEAK UNDER THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM IN THE HYDROPNEUMATIC AREA. THE CUSTOMER CLEANED THE LEAK AND THOUGHT THAT IT WAS DEIONIZED (DI) WATER. THE CUSTOMER WAS UNABLE TO IDENTIFY SOURCE OF THE LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1