BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2001988 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00546
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION IS NOT AVAILABLE. PER CUSTOMER, NO ISSUES WERE NOTED WITH CALIBRATION AND/OR QC PRIOR TO THE EVENT. SERVICE CONTACTED THE CUSTOMER AND WAS TOLD THE GLUCOSE ACCUSENSE ELECTRODE WAS REPLACED AFTER THE CUSTOMER RECEIVED CONDUCTANCE ERROR MESSAGE. ROOT CAUSE APPEARS TO BE THE ELECTRODE. NO OTHER ISSUES SEEN AFTER REPLACING THE ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO SEVEN DISCREPANT GLUCOSE MODULAR (GLUM) PATIENT RESULTS WHICH WERE OUTSIDE THE LABORATORY'S CRITERIA FOR DUPLICATE REPRODUCIBILITY. THE RESULTS WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER HAS A CRITERIA OF 8MG/DL FOR <110 MG/DL AND 12 MG/DL FOR >110MG/DL. IF IT EXCEEDS THE CRITERIA, THEN THEY RERUN THE SAMPLES AGAIN. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE NO IMPACT TO PATIENT. QA WAS UNABLE TO OBTAIN THE ACTUAL PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, CGA BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1