FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00089
MDR report key: 1003029
·
Received February 11, 2008
Report
- Report Number
- 2250051-2008-00089
- Event Type
- Malfunction
- Date Received
- February 11, 2008
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. ORTHO-CLINICAL DIAGNOSTICS CUSTOMER TECHNICAL SERVICES (CTS) WAS CONTACTED AND THE CTS INSTRUCTED THE USER TO CLEAN THE SCANNER LENS. THE USER REPORTS THIS FIXED THE PROBLEM. THE INSTRUMENT TO OPERATING AS EXPECTED. NO REPAIRS WERE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |