BEUDAMED
    FDA Adverse Event Summary report: N

    GE LUNAR PRODIGY ADVANCE

    MDR report key: 2123682 · Received June 9, 2011

    Report

    Report Number
    2123682
    Date Received
    June 9, 2011
    Date of Event
    January 4, 2011
    Report Date
    May 17, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    KGI
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    THE GE LUNAR SYSTEM HAD TO BE RESET. WHEN IT WAS RESET, THE POPULATION COMPARISON GROUP NEEDED TO BE SELECTED. THE COMPARISON GROUP "USA" WAS SELECTED, NOT "USA/NHANES" THIS CAUSED THE WRONG CALCULATION OF BONE LOSS. STAFF REPORTED THAT WHEN THE COMPARISON GROUP IS SELECTED, THE LIST OF COMPARISON GROUPS IS SO LONG THAT ONE NEEDS TO SCROLL THROUGH MANY SELECTIONS AND THE PROPER REFERENCE DATABASE IS NOT SEEN EASILY. THE LIST OF COMPARISON GROUPS INCLUDES MANY COUNTRIES OUTSIDE OF THE US THAT WOULD NOT BE SELECTED IN THE US. IF THE LIST WAS NOT AS LONG IT WAS FELT THAT THERE WOULD NOT BE THE RISK OF SELECTING THE WRONG REFERENCE DATABASE. STAFF SUGGESTED THAT THE LIST BE MODIFIED FOR US USERS SO THAT SO MANY UNNEEDED COMPARISON GROUPS DO NOT APPEAR.THE RESULT WAS INCORRECT DATA FOR 223 PATIENT EXAMS.THE SETTINGS WERE CORRECTED. THE MANUFACTURER WAS CONTACTED AND INSTRUCTIONS WERE GIVEN ON HOW TO CORRECT AND REANALYZE THE DATA. THE EXAMS WERE REANALYZED TO CORRECT THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE LUNAR PRODIGY ADVANCE BONE DENSITOMETER KGI GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR