BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3200733 · Received July 1, 2013

    Report

    Report Number
    2050012-2013-00437
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE CAP PIERCER SHUTTLE, 3-WAY VALVE, AND QUAD RING TO RESOLVE THE LEAK. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RESULTS: FAILURE MODE IS UNKNOWN BUT REPLACING THE CAP PIERCER SHUTTLE, 3-WAY VALVE, AND QUAD RING RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING FLUID ON TOP OF THE COMPLETED SAMPLE RACKS INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER COULD NOT DETERMINE THE EXACT SOURCE OF THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297287 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1