BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143417 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02521
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 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
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE STATED "PROBE MAY HAVE ASPIRATED SOME GEL." THE FSE FLUSHED THE PROBE AND CLEANED THE WASH COLLARS. PER FSE, THE ANALYZER WAS RUNNING MANY SAMPLES WITHOUT ANY FLOODING. A CLEAR ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THEY HAD MODULAR CHEMISTRIES (MC) SAMPLE PROBE OBSTRUCTION ERRORS ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER INDICATED THAT ERRORS WENT AWAY, BUT LATER THEY FOUND LEAKAGE FROM THE PROBE ONTO THE SAMPLE RACKS ON THE SAMPLE WHEEL. A CUSTOMER TECHNICAL SUPPORT (CTS) GENERATED A SERVICE REQUEST. 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 SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1