N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 8225989
- MDR report key
- 8225989
- Report number
- 3008344661-2019-00004
- Event key
- 0
- Event type
- 3
- Date received
- 2019-01-08
- 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 CEA | CARCINOEMBRYONIC ANTIGEN | ABBOTT IRELAND | DHX | 07K68-27 | 88126FN00 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-08 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED FALSE DECREASED ARCHITECT CEA RESULT FOR A RECENTLY DIAGNOSED COLON CANCER PATIENT. THE FOLLOWING CEA RESULTS WERE PROVIDED: 10/18: 6.6 NG/ML; 12/4: 4.8 NG/ML. THE CUSTOMER REPORTS NO TREATMENT WAS DONE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.