BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2123920 · Received June 14, 2011

    Report

    Report Number
    2050012-2011-02299
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WANTED TO REMOVE THE NO FOAM BOTTLE AND EMPTY IT. HOTLINE RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT (PPE) BEFORE TROUBLESHOOTING. CUSTOMER STATED THAT THEY EMPTIED THE NO FOAM CANISTER AND THE ANALYZER IS OPERATIONAL. HOTLINE ADVISED CUSTOMER TO CHECK THE HYDRO FOR LEAKS AND CUSTOMER STATED THAT THERE ARE NO LEAKS. CUSTOMER WILL MONITOR AND CALL BACK IF PROBLEM CONTINUES. AS OF (B)(4) 2011, NO FURTHER RELATED ISSUES OCCURRED AS SEEN IN THE SERVICE HISTORY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT THEY HAD SEVERAL ERRORS ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM AND SOMETHING BACKUP INTO THE NO FOAM BOTTLE. NO INJURY WAS REPORTED ON THIS ISSUE.

    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. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1