MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS LLC BIOFIRE FILMARRAY GASTROINTESTINAL PANEL; QUANTITATIVE AND QUANTITATIVE MULTIPLEX NUCLEIC ACID DETECTION SYSTEM

Lot Number 416619

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

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.

• Brand Name: BIOFIRE FILMARRAY GASTROINTESTINAL PANEL
• Type of Device: QUANTITATIVE AND QUANTITATIVE MULTIPLEX NUCLEIC ACID DETECTION SYSTEM
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS LLC
• MDR Report Key: 8374968
• MDR Text Key: 137555228
• Report Number: MW5084453
• Device Sequence Number: 1
• Product Code: PCH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 416619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1