BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM WITH DUAL GANTRY

    MDR report key: 2072824 · Received April 29, 2011

    Report

    Report Number
    2122870-2011-01190
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) REPLACED THE BOARD TO RESOLVE THE ISSUE. FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. ROOT CAUSE IS ASSOCIATED WITH THE HARDWARE.

    Description of Event or Problem · 1

    WHEN A BECKMAN COULTER INC. (BCI) FIELD SERVICE ENGINEER (FSE) WAS PERFORMING AN INSTALL OF THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM WITH DUAL GANTRY , THE REAGENT STORAGE WAS UNABLE TO INITIALIZE. FSE FOUND A BURNED COMPONENT ON THE REAGENT STORAGE PCB. THERE WAS NO REPORT OF A BURNING OR ELECTRICAL SMELL AT THE TIME OF EVENT. THERE WERE NO INJURY, NO SMOKE, OR FLAMES. THE FIRE DEPARTMENT WAS NOT DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM WITH DUAL GANTRY DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600

    Patients

    Seq Age Sex Outcome Treatment
    1