BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1984341 · Received February 10, 2011

    Report

    Report Number
    2050012-2011-00420
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FLUSHED THE PORTS OF THE EIC AND TRIED REPLACING THE QUAD RING, BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER ALSO TRIED REPLACING THE EIC WITH A USED ONE, BUT THE LEAK STILL OCCURRED AT THE BOTTOM OF THE EIC. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE EIC BOTTOM AND THE EIC VALVES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ELECTROLYTE INJECTION CUP (EIC) WAS OVERFLOWING. NO INJURY OR OPERATOR 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. DXC 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1