BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2030081 · Received March 25, 2011

    Report

    Report Number
    2050012-2011-00854
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND HAD CUSTOMER CLOSE FILES AND COLD BOOT THE SYSTEM. THE CTS CALLED THE CUSTOMER AND CUSTOMER STATED THAT FLUID WAS NO LONGER LEAKING. THERE HAVE BEEN NO FURTHER LEAKING COMPLAINT AS OF (B)(4) 2011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE LEAK WAS COMING OUT OF THE LOW PRESSURE REG VALVE AREA. THERE WAS NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1