BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2385307 · Received December 21, 2011

    Report

    Report Number
    2050012-2011-08452
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    November 26, 2011
    Report Date
    November 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM (DXC 800) GENERATED MODULAR CHEMISTRY (MC) SAMPLE PROBE OBSTRUCTION ERRORS. CUSTOMER REPORTED THAT THERE WAS SOME DISCOLORATION IN THE COLLAR WASH. CUSTOMER REPORTED THAT THERE WAS FLUID DRIPPING FROM THE COLLAR WASH. CUSTOMER REPORTED THAT THE FLUID WAS NOT BEING "SUCKED " FROM THE COLLAR WASH. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A LARGE BUILD UP OF GEL SEPARATOR IN THE MC WASH VACUUM VALVE. THE FSE CLEANED THE VALVE. THE FSE REPLACED THE CLOGGED MC SAMPLE PROBE. THE FSE CALIBRATED THE ELECTROLYTES AND THE MODULAR CUP CHEMISTRIES. THE FSE RAN QUALITY CONTROL, ALL RESULTS WERE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1