BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1946320 · Received January 4, 2011

    Report

    Report Number
    2050012-2011-00018
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH CLEANING UP THE MATERIAL AND SENT A REPLACEMENT PRINTER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE NEWLY INSTALLED TONER CARTRIDGE IN THE PRINTER OF THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS FOUND LEAKING ALL OVER THE INSIDE OF THE PRINTER. NO INJURY REPORTED.

    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. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1