BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3112308 · Received May 14, 2013

    Report

    Report Number
    2050012-2013-00302
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) BLEACHED THE FLOWCELL, REPLACED BOTH NA ELECTRODES (MEASURING AND REFERENCE) AND INCIDENTALLY REPLACED THE CARBON BRIDGE. THE FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS UNKNOWN; ALTHOUGH THE CUSTOMER WAS USING EXPIRED MATERIAL FOR MAINTENANCE, SERVICE ALSO REPLACED BOTH THE MEASURING AND REFERENCE NA ELECTRODES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FALSE LOW NA (SODIUM) RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT SOME SAMPLES WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE CUSTOMER REPEATED THE SAMPLES ON AN ALTERNATE ANALYZER AND ISSUED AMENDED REPORTS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) PRIOR TO THE EVENT WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER HAD BEEN UP TO DATE WITH MAINTENANCE BUT HAD BEEN USING EXPIRED BLEACH AND CLENZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212010 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1