MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY PNEUMO PANEL

Model Number	RFIT-ASY-0144
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) reported a potential false positive ctx-m result on the biofire filmarray pneumonia panel (pn panel) after testing a patient's sputum sample.The customer reported that due to the pn panel result, the patient potentially received inappropriate treatment modification; however, no subsequent patient harm was reported.A potential product malfunction was identified.Biofire is currently investigating this event.Preliminary investigation indicates a malfunction associated with a high tm ctx-m signature, similarly observed with the ctx-m assay hgdna cross-reactivity.A preventive action was implemented in the fsca 5790 update software release to mitigate the potential for occurrence of ctx-m false positive results associated with human genomic dna (hgdna) cross-reactivity in the field.This software update was released in (b)(6) 2025.At the time this complaint was received, the customer had not implemented the updated software.The customer has since been advised to perform the software update.

• Brand Name: FILMARRAY PNEUMO PANEL
• Common Device Name: FILMARRAY PNEUMO PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer Contact: 515 colorow dr; salt lake city, UT 84108 ; 3857701328
• MDR Report Key: 25175369
• Report Number: 3002773840-2026-00010
• Device Sequence Number: 16093805
• Product Code: QDP
• UDI-Device Identifier: 00815381020178
• UDI-Public: 00815381020178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K243222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Model Number: RFIT-ASY-0144
• Device Lot Number: 2164125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male