FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1201423
·
Received July 24, 2008
Report
- Report Number
- 2250051-2008-00373
- Event Type
- Malfunction
- Date Received
- July 24, 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 TECHNICAL SVS REVIEWED THE CUSTOMER'S DATA FILES. INVESTIGATION INDICATES THAT THE CUSTOMER IS NOT USING AN OPTIMAL BARCODE SYMBOLOGY AND SYS 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 |