MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for Q-TEST INFLUENZA A manufactured by Becton Dickinson Microbiology System.
[13858]
In the literature provided in the test the co explains that the "method of choice" for collection of specimen is a nasal washing/aspiration. It then only provides a pharyngeal swab for use with the kit. When rptr called to ask why co had included only the swab co stated that consumer studies revealed that most physicians would not perform nasal aspirates and would prefer to collect pharyngeal swabs. Rptr's concern is that co has clearly stated in its literature that the method of choice for collection is nasal washing/aspirate. It then does not provide the practitioner with the tools to collect that specimen (tools that many practioners may not have readily available in their office). Unwitting practitioners and co are leaving themselves open for legal action if a pt has a false negative test using a specimen other than the "method of choice" and suffers complications from their illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005136 |
| MDR Report Key | 19754 |
| Date Received | 1995-02-15 |
| Date of Report | 1995-02-13 |
| Date Added to Maude | 1995-02-16 |
| 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 | Q-TEST INFLUENZA A |
| Product Code | GNX |
| Date Received | 1995-02-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19657 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEM |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-15 |