BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1970762 · Received January 25, 2011

    Report

    Report Number
    2050012-2011-00232
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT SAMPLE PROBE WAS LEAKING AFTER AN OBSTRUCTION DETECTION ERROR OCCURRED. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE COLLAR WASH VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE LEAK. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1