BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2060506 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01181
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED CUP ASSEMBLY AND ENTERED DAC VALUES. FSE VERIFIED CALIBRATION AND CONTROLS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE PRESENCE OF BLACK SUBSTANCE ON THE PHOSPHORUS MODULE WHILE PERFORMING PREVENTIVE MAINTENANCE. THE CUSTOMER REMOVED THE CUP MODULE AND FOUND A PINHOLE ON A BLACK PLATE WHEN NOTICED BLACK AND THE GLUEY SUBSTANCE DRIPPING FROM THE CUP. NO INJURY 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 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1