BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2112213 · Received June 3, 2011

    Report

    Report Number
    2050012-2011-02117
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED CUSTOMER TO DISABLE CAP PIERCER ASSAY. ON (B)(6) 2011, FIELD SERVICE ENGINEER (FSE) FOUND VACUUM LINE IS SLUGGISH. FSE ENSURED ALL CONNECTORS WERE FULLY ENGAGED AND BLEACHED LINE. WHILE PRIMING, NOTED FLUID DRIPPING FROM BOTTOM OF ACRYLIC BLOCK. FSE REMOVED ACRYLIC BLOCK AND DISCOVERED QUAD-RING WAS MISSING FROM BLACK, WASHING SHUTTLE. FSE REPLACED QUAD RING AND ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT AUTOGLOSS OVERFLOWED FROM CAP PIERCER WASH CUP AND THAT WASH CUP DOES NOT APPEARED TO BE DRAINING. THE CUSTOMER STATED THAT FLUID WAS LEAKING ONTO CAPPED SAMPLE TUBES. 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 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening