BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 2060507 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01182
    Date Received
    April 18, 2011
    Date of Event
    March 15, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CHECKED CC SAMPLE SYRINGE AND IT WAS NOT LEAKING. CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED CUSTOMER TO REPLACE CC SAMPLE SYRINGE ROD. CTS CALLED THE CUSTOMER AND CUSTOMER CONFIRMED THAT ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1