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

Model Number RFIT-ASY-0116

Device Problem False Positive Result (1227)

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

Event Date 09/04/2019

Event Type  Injury  

Event 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
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, INC.
• MDR Report Key: 9028916
• MDR Text Key: 158710052
• Report Number: MW5089772
• 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

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
• Device Operator: 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
• 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: 70 YR
• Patient Weight: 83