BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2080904 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01415
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED CUSTOMER THAT THE ABOVE LEAK CAN BE DUE TO A CLOGGED DRAIN TUBE, OR, DUE TO A FAULTY DRAIN VALVE. CTS OFFERED TO CALL THE FIELD SERVICE; HOWEVER, THE CUSTOMER DECLINED. CTS REFERRED THE CUSTOMER TO THE INSTRUCTIONS IN THE IFU TO CLEAN THE ISE DRAIN. CTS STATED THE ISE DRAIN IS STILL OVERFLOWING POST CLEANING. CUSTOMER DISCONNECTED THE DRAIN TUBING FROM THE SOLENOID AND IT STARTED TO DRAIN. CUSTOMER STATED THAT THEIR OWN BIOMED FOUND A CLOGGED LINE. NO SPECIFIC INFORMATION PROVIDED. NO FURTHER LEAKING HAS BEEN NOTED AS OF (B)(4) 2011. CUSTOMER DECLINE SERVICE

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ION-SELECTIVE ELECTRODE (ISE) DRAIN IS OVERFLOW. NO INJURY OR EXPOSURE 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. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1