MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-17 for API? RAPID 20 E 20701 manufactured by Biomerieux, Sa.
| Report Number | 9615754-2019-00087 |
| MDR Report Key | 9076609 |
| Date Received | 2019-09-17 |
| Date of Report | 2019-11-04 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2017-03-23 |
| Date Added to Maude | 2019-09-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API? RAPID 20 E |
| Generic Name | API? RAPID 20 E STRIP |
| Product Code | JSS |
| Date Received | 2019-09-17 |
| Catalog Number | 20701 |
| Lot Number | 1005589130 |
| Device Expiration Date | 2018-09-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-17 |