BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2119344 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02268
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS ADVISED THE CUSTOMER THAT THEY MAY HAVE A CLOT IN THE EIC. CTS FAXED THE CUSTOMER A PROCEDURE TO CLEAN THE EIC PORT. CUSTOMER COMPLETED THE EIC PORT CLEANING PROCEDURE AND REPORTED TO CTS THAT THE ISSUE WAS RESOLVED. EIC WAS DRAINING AND NO LONGER OVERFLOWING. NO SERVICE REQUEST GENERATED. THE CUSTOMER RESOLVED ISSUE THROUGH TROUBLESHOOTING WITH CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT ELECTROLYTE INJECTION CUP (EIC) OVERFLOWED AND NOT DRAINING. NO INJURY OR EXPOSURE WAS 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. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1