BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2535792 · Received April 13, 2012

    Report

    Report Number
    2050012-2012-00971
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISCONNECTED AND ASPIRATED THE OCCLUSION FROM THE ASSOCIATED TUBING (LINE 36) AND WAS REATTACHED. THE ISSUE WAS RESOLVED. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH ROUTINE MAINTENANCE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE FLOW CELL DRAIN CUP OVERFLOWED DUE TO A LINE OCCLUSION IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THIS EVENT OCCURRED WHILE RUNNING QUALITY CONTROLS (QC). NO ERRONEOUS RESULTS WERE GENERATED DURING THE TIME OF THE EVENT. NO INJURIES WERE SUSTAINED BY ANY LABORATORY PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1