BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2072308 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01263
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) HAD CUSTOMER STOP SYSTEM FUNCTION AND PLACE PAPER TOWELS IN COMPARTMENT. THE CUSTOMER WAS UNABLE TO LOCATE SOURCE OF LEAK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND FOUND EIC LEAKING FROM THE REAR VALVE. THE EIC WAS REPLACED ABOUT 2 WEEKS AGO. UPON INSPECTING THE EIC WHILE RUNNING, FSE FOUND REAGENT LEAKING FROM THE BACK VALVE DUE TO THE FAULTY VALVE. FSE REPLACED THE WHOLE ASSEMBLY DUE TO RUST IN SCREW PORT OF ACRYLIC BLOCK.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ELECTROLYTE INJECTION CUP (EIC) WAS LEAKING ONTO THE OVERFLOW PLATE. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1