MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL 2FA9F48F manufactured by Biomerieux / Biofire.
[104161562]
Film array biofire gastrointestinal panel detecting possible contamination (dna - non viable) with vibro cholera. Lot number 648217 ((b)(6) 2017) and lot number 800818 ((b)(6) 2018). Film array bio fire blood culture identification panel (bcid) lot 822618 ((b)(6) 2018) proteus species. Biofire communication fsca number (b)(4) dated (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076254 |
| MDR Report Key | 7388098 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-27 |
| Date Added to Maude | 2018-04-02 |
| 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 | 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 FILM ARRAY GASTROINTESTINAL GI PANEL |
| Generic Name | GASTROINTESTINAL PATHOGEN PANEL |
| Product Code | JJH |
| Date Received | 2018-03-30 |
| Model Number | 2FA9F48F |
| Lot Number | 648217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX / BIOFIRE |
| Brand Name | BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL |
| Generic Name | GASTROINTESTINAL PATHOGEN PANEL |
| Product Code | JJH |
| Date Received | 2018-03-30 |
| Model Number | 2FA90840 |
| Lot Number | 800818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX / BIOFIRE |
| Brand Name | BIOFIRE FILM ARRAY BLOOD CULTURE IDENTIFICATION PANEL |
| Generic Name | GRAM NEGATIVE BACTERIA AND RESISTANCE MARKER |
| Product Code | PEN |
| Date Received | 2018-03-30 |
| Lot Number | 822618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX / BIOFIRE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-30 |