BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2951144 · Received February 8, 2013

    Report

    Report Number
    2050012-2013-00062
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 13, 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

    FAILURE MODE WAS DETERMINED TO BE THAT THE SEAL OVER THE VALVE ARM ON VALVE V3 WAS NOT SEATED PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CAP PIERCER INVOLVING A UNICEL DXC 800 SYNCHRON SYSTEM HAD LEAKED ONTO THE SAMPLE TUBE CAPS. THE CUSTOMER STATED THAT THEY HAD CHANGED THE BLADE THE PREVIOUS DAY AND PLACEMENT OF THE BLADE WAS VERIFIED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE GLASSES AND LABORATORY COAT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THAT THE SEAL OVER THE VALVE ARM ON VALVE V3 WAS NOT SEATED PROPERLY. THE FSE REPOSITIONED THE SEAL TO RESOLVE THE ISSUE AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53851 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1