BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2042530 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00969
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION IS NOT AVAILABLE. ON (B)(4) 2011, THE CUSTOMER REPLACED THE ELECTRODE, HOWEVER DID NOT CALIBRATED AS REQUIRED ACCORDING TO CUSTOMER LABELING. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED MODULAR CHEMISTRY PROBE ALIGNMENT AND CALIBRATED THE GLUES ELECTRODE. QC MATERIAL WITHIN ESTABLISHED SPECIFICATIONS. PRECISION RUN PERFORMED AND SHOWED LOW CV'S. ROOT CAUSE APPEARS TO BE THE GLUCOSE ELECTRODE WHICH NOT CALIBRATED WHEN INSTALLED ACCORDING CUSTOMER LABELING INSTRUCTIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO GLUCOSE MODULAR (GLUM) QC DRIFT AND CALIBRATION ISSUES GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. IN ADDITION, THE INSTRUMENT PRODUCED DISCREPANT RESULTS, WHICH DID NOT CORRELATE WITH A SECOND INSTRUMENT, WHEN THE CUSTOMER RAN GLUCM PATIENT SAMPLES ON BOTH INSTRUMENTS PRIOR TO REPORTING THE RESULTS. THE DIFFERENCES BETWEEN THE RESULTS WERE 10%. PATIENT RESULTS WERE AVAILABLE FROM THE CUSTOMER NO CORRECTED REPORTS OR NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1