BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3243958 · Received July 23, 2013

    Report

    Report Number
    2050012-2013-00500
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER'S BIOMED ENGINEER DISCOVERED NO VACUUM AT THE SOLENOID VACUUM COLLAR WASH VALVE. THE BIOMED ENGINEER REPLACED THE VALVE TO RESOLVE THE ISSUE. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE SOLENOID VACUUM COLLAR WASH VALVE AND ISSUE WAS RESOLVED BY THE CUSTOMER'S BIOMED ENGINEER BY REPLACING THE AFFECTED VALVE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE CARTRIDGE CHEMISTRY (CC) PROBE B OF THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT FLUID LEAKED ONTO THE REAGENT COVER TRAY AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYEWEAR, AND A LABORATORY COAT DURING 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. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY CHANGING THE REAGENT PROBE BUT ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342765 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1