FDA Adverse Event
Other
Summary report: N
AMGA CS-400
MDR report key: 283601
·
Received June 26, 2000
Report
- Report Number
- 1938173-2000-00001
- Event Type
- Other
- Date Received
- June 26, 2000
- Date of Event
- June 18, 2000
- Report Date
- June 22, 2000
- Manufacturer
- SIGMA DIAGNOSTICS
- Product Code
- JPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SELF-LIMITING INSTRUMENT FIRE IN R & D LABORATORY. NO INJURIES DUE TO OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMGA CS-400 | COAGULATION ANALYZER | JPA | SIGMA DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |