FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1121950
·
Received June 12, 2008
Report
- Report Number
- 2250051-2008-00284
- Event Type
- Malfunction
- Date Received
- June 12, 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 A BROKEN CLAMP IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED PLUNGER CLAMP IN POSITION #7. THE INSTRUMENT WAS CLEANED, 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 |