BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2313234 · Received October 28, 2011

    Report

    Report Number
    2122870-2011-05047
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAKING LIQUID CAN POTENTIALLY CONTAIN NOT ONLY WASH BUFFER, BUT PATIENT SAMPLE WASTE, QC MATERIAL, AND OTHER SUBSTANCES THAT ARE CONSIDERED CHEMICAL AND/OR BIO-HAZARDOUS IN NATURE.SERVICE WAS ON SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND A TUBING WAS LEAKING ON THE WASTE SIDE OF THE FLUIDICS DRAWER. THE FSE REPLACED THE TUBING AND CLEANED UP THE LEAKS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM WAS LEAKING FLUID. THE CUSTOMER STATED THAT THE FLUID WAS COMING FROM THE PUMP TRAY ABOVE THE LIQUID WASTE BOTTLES. THE CUSTOMER STATED THAT NOBODY CAME IN CONTACT WITH THE FLUID WITHOUT PPE. MSDS WAS NOT REVIEWED BUT THE CUSTOMER STATED THE FACILITY HAS A HAZARDOUS EXPOSURE POLICY IN PLACE. THE CUSTOMER REPORTED THAT THERE WAS NO INJURY TO USER OR EXPOSURE TO BIO-HAZARDOUS WASTE ASSOCIATED WITH THIS EVENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1