MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE GI PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Model Number RFIT-ASY-0116

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/24/2019

Event Type  Injury  

Event Description

Discrepancies between testing for biofire gi panel.Initial specimen was submitted and tested.The following organisms were detected: campylobacter, enteroaggregative e.Coli (eaec), shigella / enteroinvasive e.Coli (eiec), and norovirus gi / gii.It was discovered the following day that the initial test was performed using an expired kit, so the test was repeated using a current lot.The repeat testing detected the following organisms: campylobacter, enteroaggregative e.Coli (eaec), enteropathogenic e.Coli (epec), shigella / enteroinvasive e.Coli (eiec), and norovirus gi/gii.Due to the discrepant results and the detection of organism, the panel was repeated once more.The 3rd run detected the following: campylobacter, enteroaggregative e.Coli (eaec), enteropathogenic e.Coli (epec), shigella / enteroinvasive e.Coli (eiec), and sapovirus.Fda safety report id# (b)(4).

• Brand Name: BIOFIRE GI PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC
• MDR Report Key: 9028561
• MDR Text Key: 158849532
• Report Number: MW5089767
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00815381020109
• UDI-Public: (01)00815381020109
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFIT-ASY-0116
• Device Catalogue Number: RFIT-ASY-0116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2019
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 52 YR