BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 2109734 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-02054
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC SAMPLE INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT CALIBRATION WAS FAILING AND OTHER CHEMISTRIES WERE HAVING PRECISION ISSUES, AND THAT QC WAS OUT OF RANGE. NO OTHER CHEMISTRY RESULTS WERE PROVIDED. REVIEW OF CUSTOMER'S CALIBRATION AND PRECISION DATA SHOWED MOST CALIBRATION PASSED BUT TG FAILED WITH BACK-TO-BACK ERRORS FOR IMPRECISION. SERVICE VISITED ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) OBSERVED IMPRECISION ON TG CONTROLS AND SAMPLES. IT WAS FOUND THAT ON THE 3RD OF MAY THE CUSTOMER HAD RUN THE MEDICA WATER SYSTEM DRY PULLING OFF WATER. THIS ALLOWED BEADS TO BE INTRODUCED INTO THE SYSTEM. BOTH MIXER WASH STATIONS WERE PLUGGED AND CUVETTE WASH STATION PROBE 2 WAS ALSO PLUGGED. THIS CAUSED CARRYOVER. THE FSE CLEANED MIXER WASH STATION INSERTS AND REPLACED CUVETTE WASH PROBE 2. THE FSE FLUSHED MIXER STATIONS AND CLEANED HYDRO DI WATER CANISTERS. SIEMENS WATER CAME IN AND PLACED A 1 MICRON FILTER ON THE OUTPUT OF THE MEDICA TO PREVENT FURTHER ISSUES. THE FSE PERFORMED TRIG/URIC CARRYOVER TEST, WHICH PRODUCED RESULTS WITHIN THE PUBLISHED SPECIFICATIONS. THE FSE ALSO RAN 20 POINT PRECISIONS ON TG, BUN, LDH AND AMM. ALL TESTS PRODUCED RESULTS WITHIN THE PUBLISHED SPECIFICATIONS. SERVICE VISITED AGAIN ON 05/06/2011, AND REPLACED CLEANED MIXER WASH STATION INSERTS. THE FSE RAN TRIG/URIC CARRYOVER, WHICH PRODUCED RESULTS WITHIN THE SPECIFICATIONS. THE SYSTEM WAS OPERATIONAL, AND AS OF 5/10/2011, THERE HAS BEEN NO FURTHER SERVICE CALLS FOR THIS ISSUE. - (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRATIC TRIGLYCERIDES (TG) RESULTS GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED DISCREPANT RESULTS. THE RESULTS ARE SHOWN IN THE ATTACHED FILE. THE CUSTOMER INDICATED THAT THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1