BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2091513 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01808
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PERFORMED TROUBLESHOOTING (TS) WITH CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTANCE AND FOUND NO O RING INSIDE THE CONNECTION TO THE BEAD. THE CUSTOMER INSTALLED A PROBE O RING. NO FURTHER ISSUES HAVE OCCURRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE REAGENT PROBE WAS LEAKING WHERE THE PROBE MEETS THE BEAD IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    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