MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-09 for GE LUNAR PRODIGY ADVANCE * manufactured by Ge Healthcare.
[17556916]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2123682 |
| MDR Report Key | 2123682 |
| Date Received | 2011-06-09 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-01-04 |
| Report Date | 2011-05-17 |
| Date Reported to FDA | 2011-06-09 |
| Date Added to Maude | 2011-06-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE LUNAR PRODIGY ADVANCE |
| Generic Name | BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2011-06-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 9900 W. INNOVATION DR. RP 2138 WAUKESHA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-09 |