BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2264198 · Received September 26, 2011

    Report

    Report Number
    2050012-2011-05612
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    August 28, 2011
    Report Date
    August 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) FOUND THE CONTROL ISSUE WAS CAUSED BY THE CARTRIDGE CHEMISTRY SAMPLE PROBE FAILURE. THE FSE REPLACED THE MANIFOLD VALVE, THE PROBE AND THE WASH COLLAR. THIS IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DIFFERENT DAYS. THIS MDR IS RELATED TO MDR# 2050012-2011-05614.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) ON (B)(6), 2011 THAT REAGENT PROBE B OF THE UNICEL DXC 600 SYNCHRON SYSTEM IS LEAKING WITH DILUTED WASH. CUSTOMER REPORTED THAT THERE WERE SPORADIC CUVETTES NOT PASSING H20 BLANKS AND COLLEGE OF AMERICAN PATHOLOGIST (CAP) BIAS WITH ASPARTATE AMINOTRANSFERASE (AST) AND ALAININE AMINOTRANSFERASE (ALT). TO RESOLVE THE ISSUE, CUSTOMER DECIDED TO FLUSH ONE OF THE TUBES FROM THE WASH CONCENTRATE BOTTLE. CUSTOMER REPORTED THAT PATIENT SAMPLES HAVE NOT BEEN RUN AS THE QUALITY CONTROL RESULTS WERE NOT SATISFACTORY. THERE WERE NO ERRONEOUS RESULTS GENERATED BY THE INSTRUMENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1