BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1997109 · Received February 21, 2011

    Report

    Report Number
    2050012-2011-00515
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THERE IS A BROKEN Y FITTING IN HYDRO AND NO FOAM IS LEAKING FROM IT. SERVICE WAS NOT DISPATCHED. A FIELD SERVICE ENGINEER (FSE) SENT THE PART TO THE CUSTOMER TO REPLACE THE Y FILLING. FSE VERIFIED CUSTOMER HAD REPLACED THE Y FITTING AND NO LEAKS WERE NOTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NO FOAM SOLUTION LEAK. NO INJURY OR EXPOSURE WAS REPORTED. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1