BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2940427 · Received February 3, 2013

    Report

    Report Number
    2050012-2013-00064
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OBSTRUCTED ELECTROLYTE INJECTION CUP (EIC). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING THE ELECTROLYTE INJECTION CUP (EIC) OVERFLOWING WHILE CHANGING THE ELECTROLYTE REAGENTS ON A UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT AS THE ION SELECTIVE ELECTRODE (ISE) MODULE WAS PRIMED, THE SAMPLE INJECTION PORT WOULD GRADUALLY FILL AND EVENTUALLY OVERFLOW. THE CUSTOMER NOTED THAT APPROXIMATELY 20 MILILITERS OF FLUID HAD SPILLED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THE EIC OBSTRUCTED. THE FSE FLUSHED AND CLEANED THE EIC AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE WAS DETERMINED TO BE AN OBSTRUCTED EIC AND ISSUE WAS RESOLVED FOLLOWING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45722 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1