MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for BIOFIRE FILMARRAY GASTROINTESTINAL PANEL manufactured by Biofire Diagnostics Llc.
[137555228]
Recent lots of the biofire filmarray gastrointestinal panel have yielded false detection of campylobacter species in clinical stool specimens. Seven patients received false positive results from the biofire filmarray gastrointestinal panel for campylobacter species in stool between (b)(6) 2019. These results were not reproducible by the filmarray assay and were negative by confirmatory stool culture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084453 |
| MDR Report Key | 8374968 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-22 |
| Date Added to Maude | 2019-02-27 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOFIRE FILMARRAY GASTROINTESTINAL PANEL |
| Generic Name | QUANTITATIVE AND QUANTITATIVE MULTIPLEX NUCLEIC ACID DETECTION SYSTEM |
| Product Code | PCH |
| Date Received | 2019-02-26 |
| Lot Number | 416619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFIRE DIAGNOSTICS LLC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |