MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-06 for WEST NILE VIRUS ASSAY * manufactured by Not Identified.
[595188]
Patient received: 1) incorrect test results from use of fda approved or "new" screening test for west nile virus in donated blood. 2) event occurred at blood donor unit. 3) incorrect results caused donor's blood to be refused for transfusion and discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041853 |
| MDR Report Key | 813190 |
| Date Received | 2007-02-06 |
| Date of Report | 2007-01-29 |
| Date of Event | 2006-12-14 |
| Date Added to Maude | 2007-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | WEST NILE VIRUS ASSAY |
| Generic Name | NUCLEIC ACID TEST (NAT) |
| Product Code | NOP |
| Date Received | 2007-02-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800675 |
| Manufacturer | NOT IDENTIFIED |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-02-06 |