MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, INC. BIOFIRE GI PANEL; GASTROINTESTINAL PATHOGEN PANEL

Model Number	RFIT-ASY-0116
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Possible false positive vibrio cholera detected and reported.Pt was transferred to a new facility and also placed on tetracycline for vibrio infection.Fda safety report id# (b)(4).

• Brand Name: BIOFIRE GI PANEL
• Common Device Name: GASTROINTESTINAL PATHOGEN PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, INC.
• MDR Report Key: 9028916
• Report Number: MW5089772
• Device Sequence Number: 19452070
• Product Code: PCH
• UDI-Device Identifier: 00815381020109
• UDI-Public: (01)00815381020109
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2020
• Device Model Number: RFIT-ASY-0116
• Device Catalogue Number: RFIT-ASY-0116
• Device Lot Number: 779519
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 70 YR
• Patient Weight: 83