BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600 PACKAGED

    MDR report key: 1980765 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00386
    Date Received
    February 7, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE EIC CUP WAS CLEANED AND THE CALCIUM TIP WAS CHANGED. NO ISSUES WERE NOTED UNTIL THIS EVENT. A BCI FIELD SERVICE ENGINEER (FSE) FOUND RUBBER SHAVINGS FROM THE SAMPLE TUBE STOPPERS IN BOTH THE EIC CUP VALVES AND THE CUP, WHICH RESULTED IN IMPROPER OPERATION AND DRAINAGE. FSE CLEANED THE VALVES AND THE CUP. EIC IS WORKING PROPERLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELECTROLYTE INJECTION CUP (EIC) SPEWING VISCOUS MATERIAL. NO AFFECT TO ANY PERSONNEL OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 PACKAGED CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1