MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-02 for DIRECTIGEN FLU-A manufactured by Becton Dickinson Microbiolgy Systems.
[36543]
There were five instances in which the diagnostic tests tested negative; although when cultured, all (5) tested positive for the influenza a virus. Event date: within last 3 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010499 |
| MDR Report Key | 59768 |
| Date Received | 1997-01-02 |
| Date of Report | 1997-01-02 |
| Date Added to Maude | 1997-01-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTIGEN FLU-A |
| Generic Name | DIAGNOSTIC TEST FOR INFLUENZA A VIRUS |
| Product Code | GNT |
| Date Received | 1997-01-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 38004562 |
| ID Number | NA |
| Device Expiration Date | 1997-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 60183 |
| Manufacturer | BECTON DICKINSON MICROBIOLGY SYSTEMS |
| Manufacturer Address | 250 SCHILLING CIRCLE PO BOX 243 COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-02 |