MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-17 for ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM * 930740 manufactured by Ortho-clinical Diagnostics, Inc..
[374455]
The ortho hcv version 3. 0 elisa test system was used for diagnostic testing and reportedly generated a false negative result. No death or serious injury was assoicated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2005-50092 |
| MDR Report Key | 584498 |
| Date Received | 2005-03-17 |
| Date of Report | 2005-03-17 |
| Date of Event | 2005-02-17 |
| Date Added to Maude | 2005-03-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM |
| Generic Name | ANTIBODY TO HCV ELISA TEST KIT |
| Product Code | LQI |
| Date Received | 2005-03-17 |
| Model Number | * |
| Catalog Number | 930740 |
| Lot Number | TXE389 |
| ID Number | * |
| Device Expiration Date | 2005-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 574329 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-17 |