N
Patient 1
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 8348266
- MDR report key
- 8348266
- Report number
- 3008344661-2019-00016
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-18
- 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 AFP | ALPHA-FETOPROTEIN | ABBOTT IRELAND | LOK | 03P36-25 | 91429FN00 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-18 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED DISCREPANT ALPHA 1 FETOPROTEIN (AFP) RESULTS ON THE ARCHITECT ANALYZER. THE FOLLOWING DATA PROVIDED: INITIAL 14, REPEATS 10, 20 FOR A PATIENT BETWEEN THE AGES OF 1 AND 3 YEARS OLD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.