MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for ID NOW INFLUENZA A & B2 manufactured by Alere Scarborough, Inc..
[134789584]
The point of care test (poct) is to measure rapid flu testing and has false a and b positive results. It does not show an error code or show that the test could not be resulted if not run correctly. Instead it is providing a positive result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8288956 |
| MDR Report Key | 8288956 |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-01 |
| Report Date | 2019-01-18 |
| Date Reported to FDA | 2019-01-18 |
| Date Reported to Mfgr | 2019-01-30 |
| Date Added to Maude | 2019-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ID NOW INFLUENZA A & B2 |
| Generic Name | RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM |
| Product Code | OCC |
| Date Received | 2019-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SCARBOROUGH, INC. |
| Manufacturer Address | 10 SOUTHGATE RD SCARBOROUGH ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |