BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2510095 · Received March 29, 2012

    Report

    Report Number
    2050012-2012-00804
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO REPORTABLE EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR#2050012-2012-00805.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED AN ERRONEOUS SODIUM RESULT. CUSTOMER REPORTED THAT THE RESULT WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE DOCTOR QUESTIONED THE RESULT. CUSTOMER REPORTED THAT THE SAMPLE WAS RERUN ON THE CX INSTRUMENT IN THE LABORATORY. CUSTOMER REPORTED THAT THE CX INSTRUMENT GAVE A LOWER RESULT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE ION SELECTIVE ELECTRODE SYSTEM AND VERIFIED PERFORMANCE.

    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. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1