FDA Adverse Event
Malfunction
Summary report: N
CELL-DYN RUBY ANALYZER
MDR report key: 1171506
·
Received September 17, 2008
Report
- Report Number
- 2919069-2008-00705
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 29, 2008
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELLDYN
- Product Code
- GKZ
- PMA / PMN Number
- K061667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-DYN RUBY ANALYZER | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELLDYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |