MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-18 for HOLOGIC QDR * manufactured by Hologic, Inc..
[16643692]
Patient undergoing her first bone densitometry. When the study was read and interpreted, the software allowed a comparison to another patient's study. This was discovered when the patient called to report that she had not had a previous study to compare with. The study was re-analyzed and the error found. Dept is currently in the process of re-analyzing all studies performed on this equipment to be sure same or similar error did not occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1971896 |
| MDR Report Key | 1971896 |
| Date Received | 2011-01-18 |
| Date of Report | 2011-01-18 |
| Date of Event | 2010-12-22 |
| Report Date | 2011-01-18 |
| Date Reported to FDA | 2011-01-18 |
| Date Added to Maude | 2011-01-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HOLOGIC QDR |
| Generic Name | BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2011-01-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 35 CROSBY DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-18 |