MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-19 for REMEL XPECT INFLUENZA A&B KIT * 24600 manufactured by Remel.
[458075]
Our hospital used remel xpect influenza a&b testing screen. Yesterday we had our second false positive reaction. Last week we encountered another incident where the test says influenza is present but when you repeat the test it is negative. This was reported to the co. Remel is investigating. We issued amended reports on each pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038748 |
| MDR Report Key | 709241 |
| Date Received | 2006-04-19 |
| Date of Report | 2006-04-19 |
| Date of Event | 2006-04-18 |
| Date Added to Maude | 2006-05-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | REMEL XPECT INFLUENZA A&B KIT |
| Generic Name | * |
| Product Code | GRP |
| Date Received | 2006-04-19 |
| Model Number | * |
| Catalog Number | 24600 |
| Lot Number | 618582 |
| ID Number | * |
| Device Expiration Date | 2006-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 698285 |
| Manufacturer | REMEL |
| Manufacturer Address | 12076 SANTA FE DR PO BOX 14428 LENEXA KS 66215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-19 |