MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-10 for OUICKVUE+ RAPID STREP A TEST * manufactured by Quidel Corp.
[342232]
Discrepancy between kit instructions and actual test. The kit instructs technologist to incubate test cassette (after reagents are added) for 5 minutes. The test is only valid after test complete window is blue which takes 8-10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030489 |
| MDR Report Key | 502032 |
| Date Received | 2003-12-10 |
| Date of Report | 2003-10-01 |
| Date Added to Maude | 2003-12-22 |
| 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 |
| 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 | OUICKVUE+ RAPID STREP A TEST |
| Generic Name | * |
| Product Code | GTY |
| Date Received | 2003-12-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | ALL LOTS |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 490821 |
| Manufacturer | QUIDEL CORP |
| Manufacturer Address | 10165 MCKELLAR COURT SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-10 |