FDA Adverse Event
Death
Summary report: N
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
MDR report key: 530172
·
Received June 16, 2004
Report
- Report Number
- 2916556-2004-00003
- Event Type
- Death
- Date Received
- June 16, 2004
- Date of Event
- May 21, 2004
- Report Date
- June 15, 2004
- Manufacturer
- ADAC LABORATORIES
- Product Code
- MUJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT MISTREATMENT ISSUE OCCURRING AT ONE (1) HOSPITAL SITE. THE REPORTED PT MISTREATMENT ISSUE WAS AN OVERDOSE OF RADIATION OF 13.8% TO ONE PT. THE ONE PT SUBSEQUENTLY DIED AS A RESULT OF COMPLICATIONS RELATED TO THE MISTREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | RADIATION THERAPY PLANNING SOFTWARE | MUJ | ADAC LABORATORIES | 9200-0613A-ENG | SOFTWARE VERS 6.2B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |