FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1113363
·
Received June 9, 2008
Report
- Report Number
- 2250051-2008-00263
- Event Type
- Malfunction
- Date Received
- June 9, 2008
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT REQUEST SVC ACTIVITY. CUSTOMER TECH SVS REVIEWED THE CUSTOMER'S DATA FILES. INVESTIGATION INDICATES THAT THE CUSTOMER IS NOT USING AN OPTIMAL BARCODE SYMBOLOGY AND SYSTEM SETTING. THE CUSTOMER HAS BEEN INFORMED OF THE RESULTS OF THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | JTC | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |