BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1912912 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01441
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND OBSTRUCTION DETECTOR HAD RUPTURED MEMBRANE AND LARGE AMOUNT OF SST GEL IN MC WAS COLLAR. THE FSE REPLACED THE PARTS AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEY NOTICED FLUID THAT WAS LEAKING FROM THE MODULAR CHEMISTRIES (MC) SAMPLE PROBE ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. NO PATIENTS WERE AFFECTED. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1