BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3243967 · Received July 23, 2013

    Report

    Report Number
    2050012-2013-00503
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DETERMINED THAT VALVE J2 (ISE CIGAR TUBE DRAIN VALVE) WAS NOT FUNCTIONING AS INTENDED. THE FSE REPLACED THE ISE WASTE VALVE TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE ISE J2 WASTE VALVE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ION SELECTIVE ELECTRODE (ISE) ANALYTES OF THE UNICEL DXC 600 SYNCHRON SYSTEM FAILED TO CALIBRATE. UPON FURTHER INVESTIGATION, THE CUSTOMER DISCOVERED THAT APPROXIMATELY 1/2 CUP OF FLUID HAD OVERFLOWED FROM THE ISE DRAIN DOWN TO THE ISE MODULE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND GOGGLES 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342767 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1