FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 954653
·
Received August 10, 2006
Report
- Report Number
- 2250051-2006-00343
- Event Type
- Malfunction
- Date Received
- August 10, 2006
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SVC ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED ALL THE TIP CLAMPS, LDD CONTACT SPRINGS, AND THE PLUNGER CLAMP IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE INSTRUMENT WAS INSPECTED, TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO SVC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | JTC | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |