N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 8188954
- MDR report key
- 8188954
- Report number
- 3008344661-2018-00110
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-06
- Date received
- 2018-12-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NOEMI ROMERO-KONDOS, RN BSN
- Address
- 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
- Phone
- 224-224-2246
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT TOTAL PSA | TOTAL PSA | ABBOTT IRELAND | MTF | 06C06-27 | 89009FN00 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-21 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL PSA RESULT ON THE ARCHITECT I1000SR AANLYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(4) INITIAL 32.64 NG/ML REPEATED 0.12, 0.14 AND 0.12. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.