MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-24 for FILMARRAY? MENINGITIS/ENCEPHALITIS (ME) PANEL RFIT-ASY-0118 manufactured by Biofire Diagnostics, Llc.
Report Number | 3002773840-2019-00006 |
MDR Report Key | 9111883 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-09-24 |
Date of Report | 2019-10-18 |
Date of Event | 2019-06-27 |
Date Mfgr Received | 2019-09-12 |
Date Added to Maude | 2019-09-24 |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FILMARRAY? MENINGITIS/ENCEPHALITIS (ME) PANEL |
Generic Name | FILMARRAY ME PANEL |
Product Code | PLO |
Date Received | 2019-09-24 |
Model Number | RFIT-ASY-0118 |
Catalog Number | RFIT-ASY-0118 |
Lot Number | 0454919 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
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 | 2019-09-24 |