FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1210864
·
Received July 30, 2008
Report
- Report Number
- 2250051-2008-00390
- Event Type
- Malfunction
- Date Received
- July 30, 2008
- 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 FOUND DRIED SPECIMEN COATED ON THE TIP CLAMP, SLEEVE AT POSITION 8. FSE CLEANED ALL TIPS CLAMPS, PLUNGER CLAMPS, SLEEVES AND COMPRESSION SPRINGS. 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 | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |