BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1964442 · Received January 19, 2011

    Report

    Report Number
    2050012-2011-00142
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED TROUBLESHOOTING. THE FSE BLEACHED THE TUBING TO CLEAR THE SAMPLE PATHWAY AND REPLACED THE PERI-PUMP TUBING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A LEAK WAS OBSERVED ON THE CLOSED TUBE ALIQUOTTER (CTA) UNIT LOCATED IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER OBSERVED THAT THE OVERFLOW BOTTLE WAS FILLED WITH LIQUID AND VISIBLE DEBRIS INSIDE THE BOTTLE. THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. NO OPERATOR EXPOSURE WAS NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1