FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00062
MDR report key: 1002846
·
Received January 31, 2008
Report
- Report Number
- 2250051-2008-00062
- Event Type
- Malfunction
- Date Received
- January 31, 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 COLLET CONTAMINATED WITH SERUM IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE TIP EJECT SLEEVE WAS CLEANED AND THE TIP CLAMP WAS REPLACED. THE INSTRUMENT WAS INSPECTED, TESTED WITHOUT FURTHER PROBLEM AND RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |