BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2037196 · Received April 4, 2011

    Report

    Report Number
    2050012-2011-00871
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOTLINE ASSISTED THE CUSTOMER TO TROUBLESHOOT THE SYSTEM BY FLUSHING THE CC SAMPLE PROBE, BUT THE DRIP PERSISTED AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE INSPECTED THE INSTRUMENT AND FOUND A CLOT IN THE WASTE VALVE. THE FSE CLEANED THE WASTE VALVE AND RE-INSTALLED THE VALVE. THE CUSTOMER PERFORMED QC AND THE SYSTEM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT CONTROLS WERE LOW AND SUPPRESSED FOR CARTRIDGE CHEMISTRIES (CC) ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. HOTLINE ASKED CUSTOMER TO DO VISUAL INSPECTION OF TOP END OF THE INSTRUMENT AND THERE WAS A PUDDLE UNDER THE CC SAMPLE PROBE. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1