BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2749331 · Received September 18, 2012

    Report

    Report Number
    2050012-2012-01458
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON (B)(4) 2012, BECKMAN COULTER, INC. FIELD SERVICE ENGINEER REPLACED THE CARBON BRIDGE AND VERIFIED PERFORMANCE.THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR# 2050012-2012-01480.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED ERRONEOUS SODIUM RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE AMENDED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE SODIUM MEASURING ELECTRODE AND THE REFERENCE ELECTRODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1