GE LUNAR PRODIGY ADVANCE
Received Jun 9, 2011 · Event occurred Jan 4, 2011
Report 2123682 · MDR key 2123682
Device
Product problems
- Incorrect Software Programming Calculations
- Use of Device Problem
- Incorrect Or Inadequate Test Results
Patient
53 YR
- No Information
Narrative
Description of Event or Problem
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.