BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2120796 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02192
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) DIRECTED CUSTOMER TO VERIFY SAMPLE PROBE FITTING AND CC SAMPLE SYRINGE ASSEMBLY WERE TIGHT. THE CUSTOMER STATED THAT CC SAMPLE PROBE VACUUM LINE ON THE COLLAR WASH WAS NOT VACUUMING LIQUID PROPERLY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED SERVICE ON THE INSTRUMENT. FSE REPLACED CC SYRINGE 3-WAY VALVE AND TUBING TO TRANSDUCER AND PROBE. FSE VERIFIED INSTRUMENT PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A PUDDLE OF LIQUID ON TOP OF THE REACTION WHEEL COVER OF THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM BELOW CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE. 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