BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2042715 · Received April 6, 2011

    Report

    Report Number
    2122870-2011-00897
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOTLINE ADVISED THE CUSTOMER NOT TO USE THE INSTRUMENT AND SCHEDULED A SERVICE VISIT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED THE INSTRUMENT AND DETERMINED THE LEAK ORIGINATED FROM THE WASH BUFFER TRANSFER PUMP TUBING. THE FSE REPLACED THE WASH BUFFER TRANSFER PUMP TUBING. HARDWARE IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED BECKMAN COULTER INC., (BCI) HOTLINE REGARDING A FLUID LEAK COMING FROM THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. CUSTOMER STATED THE FLUID HAD LEAKED FROM THE FLUID TRAY ONTO THE FLOOR. THE CUSTOMER CONFIRMED TO HOTLINE THERE WAS NO EXPOSURE OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1