MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-07-11 for FILMARRAY? GASTROINTESTINAL (GI) PANEL RFIT-ASY-0116 manufactured by Biofire Diagnostics, Llc.
| Report Number | 3002773840-2019-00004 |
| MDR Report Key | 8782289 |
| Report Source | LITERATURE |
| Date Received | 2019-07-11 |
| Date of Report | 2019-07-11 |
| Date Mfgr Received | 2019-06-17 |
| Date Added to Maude | 2019-07-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. KRISTEN KANACK |
| Manufacturer Street | 515 COLOROW DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal | 84108 |
| Manufacturer Phone | 8017366354 |
| Manufacturer G1 | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Street | 515 COLOROW DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILMARRAY? GASTROINTESTINAL (GI) PANEL |
| Generic Name | FILMARRAY? GASTROINTESTINAL (GI) PANEL |
| Product Code | PCH |
| Date Received | 2019-07-11 |
| Model Number | RFIT-ASY-0116 |
| Catalog Number | RFIT-ASY-0116 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Address | 515 COLOROW DRIVE SALT LAKE CITY UT 84108 US 84108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-11 |