BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1871851 · Received October 16, 2010

    Report

    Report Number
    2050012-2010-00981
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISCOVERED THAT A LINE WAS PULLED OFF THE ISE MODULE AND FIXED THE LEAK. BCI HOTLINE ADVISED THE CUSTOMER TO MONITOR THE SYSTEM.

    Description of Event or Problem · 1

    WHILE PERFORMING DAILY MAINTENANCE, THE CUSTOMER REPORTED A BLACK TRAY UNDER THE ISE MODULE WAS FULL OF LIQUID. THE LIQUID OVERFLOWED ONTO THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1