FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 1182396
·
Received September 11, 2008
Report
- Report Number
- 1628664-2008-00216
- Event Type
- Other
- Date Received
- September 11, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 18, 2008
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- PMA / PMN Number
- K950915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |