BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2242321 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05087
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE FOUND THE CUP TO BE CLOGGED. THE FSE FLUSHED THE CUP WITH WARM DI WATER WHICH RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A LEAK IN CONNECTION WITH A UNICEL DXC 800 SYNCHRON SYSTEM. LIQUID IN THE ALBUMIN MODULE OVERFLOWED AND SPILLED OUT OF THE CUP. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1