BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2001960 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00561
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER MENTIONED THAT THE INSTRUMENT HAD BEEN GIVING HYDRO ERRORS OCCASIONALLY. THE CUSTOMER DID NOT SPECIFY THE ERROR. THE CUSTOMER REQUESTED SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER NOTICED A HISSING SOUND FROM THE INSTRUMENT AND FOUND WATER SPRAYING BY THE WASTE SUMP BUT WAS UNABLE TO DETERMINE THE SOURCE OF THE LEAK. THE CUSTOMER STATED ONLY A COUPLE OF TEASPOONFUL OF LIQUID LEAKED. NO OPERATOR EXPOSURE WAS NOTED AND 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