BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2101138 · Received May 24, 2011

    Report

    Report Number
    2122870-2011-01556
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 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

    A FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE TUBING IN THE TRANSFER PUMP HAD A CRACK IN IT. THE FSE REPLACED THE WASTE PERI-PUMP TUBING AND VERIFIED THE SYSTEM FOR PROPER OPERATION. HARDWARE IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LEAK COMING FROM THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FROM FLUIDS TRAY OVER THE LIQUID WASTE COMPARTMENT THE CUSTOMER CONFIRMED THAT PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN WHEN CLEANING UP THE LEAK. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1