BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    MDR report key: 2202959 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02899
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE LEAK APPEARED TO BE COMING FROM THE WASH BUFFER PERI PUMP TUBING. FSE REPLACED THE TUBING AND VERIFIED ALL TESTING MET SPECIFICATIONS. HARDWARE HAS BEEN DETERMINED TO BE THE ROOT CAUSE. 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 ABOVE THE LIQUID WASTE DRAWER ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT TO CLEAN THE SPILL. CUSTOMER TECHNICAL SUPPORT ADVISED THE CUSTOMER TO STOP RUNNING TESTS ON THE SYSTEM. NO REPORT OF AN AFFECT TO PATIENTS OR END USERS IN ASSOCIATION TO THIS EVENT. NO EXPOSURE TO BIOHAZARD LIQUID WASTE 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