BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3982408 · Received August 6, 2014

    Report

    Report Number
    2050012-2014-00369
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER FOUND THE ION-SELECTIVE ELECTRODE DRAIN TUBE (CIGAR TUBE) NOT DRAINING DUE TO A FAULTY BURKERT ION-SELECTIVE ELECTRODE DRAIN VALVE. THE FIELD SERVICE ENGINEER REPLACED THE BURKERT ION-SELECTIVE ELECTRODE DRAIN VALVE TO RESOLVE THE ISSUE. THE FIELD SERVICE ENGINEER VERIFIED INSTRUMENT OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ONE FALSE HIGH NA (SODIUM) AND CALC (CALCIUM) RESULT AND FALSE LOW CL (CHLORIDE) RESULT FOR ONE (1) PATIENT INVOLVING THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED "SAMPLE REFERENCE DRIFT" ERROR MESSAGES AT THE TIME OF THE EVENT. THE INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY BUT THE RESULTS WERE AMENDED WHEN THE SAMPLE WAS RERUN. THE CUSTOMER DID NOT PROVIDE (DATE OF BIRTH, AND WEIGHT) FOR THIS EVENT. THERE WAS NO CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT. QC (QUALITY CONTROL) WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461961 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR