MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-05 for ABBOTT SIGNIFY STREP A TEST KIT * manufactured by Abbott Laboratoires.
[409439]
There were changes made to the test kit components of the abbott signify strep a test kit that resulted in lower sensitivity. There was no indication on the kit itself that changes occurred. Tests conducted in lab demonstrated that the new kit has significantly lower sensitivity than the previous one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035117 |
| MDR Report Key | 589128 |
| Date Received | 2005-04-05 |
| Date of Report | 2005-04-05 |
| Date Added to Maude | 2005-04-11 |
| 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 | ABBOTT SIGNIFY STREP A TEST KIT |
| Generic Name | DIAGNOSTIC TEST KIT |
| Product Code | GTY |
| Date Received | 2005-04-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 578976 |
| Manufacturer | ABBOTT LABORATOIRES |
| Manufacturer Address | * ABBOTT PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-05 |