BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080909 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01499
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS DATA GENERATED. CONCLUSION: SAMPLE INTEGRITY AND/OR MAINTENANCE ISSUES MAY HAVE BEEN CONTRIBUTING FACTORS TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ONE ERRONEOUSLY LOW GLUCOSE RESULT WHEN RUN IN DUPLICATE MODE ON A UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE INITIAL GLUCOSE RESULT YIELDED 84 MG/DL. A REPEAT ANALYSIS FOR GLUCOSE YIELDED 71 MG/DL. AN ADDITIONAL REPEAT ANALYSIS WAS PERFORMED ON ANOTHER ANALYZER IN THE SAME LABORATORY AND YIELDED 83 MG/DL WHICH WAS REPORTED OUT OF THE LABORATORY (THE OTHER TWO PREVIOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY). PATIENT TREATMENT WAS NOT IMPACTED. THE CUSTOMER HAS EXPERIENCED SAMPLE INTEGRITY ISSUES WHICH MAY HAVE CONTRIBUTED TO THE ERRONEOUSLY LOW GLUCOSE RESULT OBSERVED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1