BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2032153 · Received March 28, 2011

    Report

    Report Number
    2050012-2011-00883
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT LEAKING UNDER THE REAGENT PROBE HAD BEEN AN ONGOING ISSUE SINCE THE WEEK BEFORE. BCI FIELD SERVICE ENGINEER (FSE) DETECTED FLUID UNDER REAGENT PROBE A. THE FSE REPLACED THE REAGENT PROBE A VALVE, BUT THE LEAKING CONTINUED. ON THE NEXT DAY, THE FSE FOUND A NICK IN THE WASH COLLAR TUBING, WHICH WAS THE CAUSE OF THE LEAK.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK FROM UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1