FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00396
MDR report key: 1232058
·
Received August 1, 2008
Report
- Report Number
- 2250051-2008-00396
- Event Type
- Malfunction
- Date Received
- August 1, 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 DRIED SERUM ON TIP AND PLUNGER CLAMPS IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED CLAMPS AND CLEANED SLEEVE. THE INSTRUMENT WAS CLEANED, TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |