BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2342562 · Received November 18, 2011

    Report

    Report Number
    2050012-2011-07492
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HEARING A POPPING NOISE, FOLLOWED BY AN ELECTRICAL BURNING SMELL AND A VOLTAGE ERROR FROM THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER TECHNICAL SPECIALIST GENERATED A SERVICE REQUEST. CUSTOMER STATED THAT NO ONE WAS AFFECTED BY THE INSTRUMENT ISSUE. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE ERROR LOG INDICATED THAT THE GLUCOSE MODULE REAGENT SYRINGE RECEIVED LOW CURRENT AT ONE POINT, WHICH CAUSED THE INSTRUMENT COMPUTER TO SHUTDOWN. THE FSE REPLACED THE POWER DISTRIBUTION BOARD. THE FSE SUSPECTED THAT THE ROOT CAUSE OF THE INSTRUMENT ISSUE WAS THE POWER DISTRIBUTION BOARD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1