BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    MDR report key: 2203211 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02898
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2011, A BEC FIELD SERVICE ENGINEER (FSE) DISCOVERED LEAKING WASH BUFFER TRANSFER PERI-PUMP TUBING IN THE FLUIDICS DRAWER. THE FSE REPLACED ALL OF THE PERI-PUMP TUBING. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. BEC INTERNAL IDENTIFICATION # IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO A FLUID LEAK INTO THE WASTE DRAWER UNDER THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE FLUID LEAK FROM THE PERI-PUMPS IS MOST LIKELY WASH BUFFER. CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) TO CLEAN UP THE SPILL. NO EXPOSURE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1