FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00345
MDR report key: 1211223
·
Received July 30, 2008
Report
- Report Number
- 2250051-2008-00345
- Event Type
- Malfunction
- Date Received
- July 30, 2008
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A TIP CLIP BROKEN IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED THE TIP CLIP AND VERIFIED THE REPAIR. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM, AND WAS RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |