BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2162702 · Received July 14, 2011

    Report

    Report Number
    2050012-2011-02963
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEVEL SENSE WAS NOT WORKING PROPERLY SO BCI CTS (CUSTOMER TECHNICAL SUPPORT) DIRECTED THE CUSTOMER TO MOVE SENSOR CIRCUIT CLOSER TO BOTTLE TO GIVE CORRECT READING. THIS RESOLVED THE ISSUE. NO SERVICE WAS REQUESTED FOR THIS EVENT. THE ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING WITH THE CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THE NO FOAM HOSE IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER CAME LOOSE FROM THE BOTTLE AND CAUSED LEAKING. THE HOSE WAS REATTACHED AND NO FURTHER LEAKING WAS OBSERVED. NO INJURY WAS REPORTED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1