MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® TORCH MODULE

Model Number	HTFA-SUB-0103
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the following biofire bcid2 panel runs were found discrepant on the filmarray torch module (b)(6): · run 1 ((b)(6) 2025) - false negative enteric 2, k.Oxytoca, oxa-48-like, and k.Pneumoniae.· run 2 ((b)(6) 2025) - false negative acb complex, e.Cloacae, enteric 2, oxa-48-like, and s.Lugdunensis.· run 3 ((b)(6) 2025) - false negative enteric 1 and s.Maltophilia.· run 4 ((b)(6) 2025) - false negative enteric 1 and k.Pneumoniae.· run 5 ((b)(6) 2025) - false negative enteric 1, k.Pneumoniae, and oxa-48-like.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the final report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Conclusion: n/a for initial report.
Event or Problem Description
Summary: (b)(6) hospital ((b)(6)) reported potential false negative results on the biofire blood culture identification 2 (bcid2) panel runs on the filmarray torch module (b)(6).No patient harm was reported.A malfunction of the filmarray torch instrument (b)(6) is suspected.A final report with all investigation details will be provided.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.
Additional Manufacturer Narrative
Investigation: patient details were not provided.No serious injury or death was reported.The following biofire bcid2 panel runs were found discrepant on the filmarray torch module (b)(6): run 1 (b)(6) 2025) - false negative enteric 2, k.Oxytoca, oxa-48-like, and k.Pneumoniae run 2 (b)(6) 2025) - false negative acb complex, e.Cloacae, enteric 2, oxa-48-like, and s.Lugdunensis.Run 3 (b)(6) 2025) - false negative enteric 1 and s.Maltophilia, run 4 (b)(6) 2025) - false negative enteric 1 and k.Pneumoniae, run 5 (b)(6) 2025) - false negative enteric 1, k.Pneumoniae, and oxa-48-like.Quality control (qc) records for pouch lot# 3nmp25 (kit lot# 0228325) and filmarray instrument (serial number# (b)(6) were reviewed.This pouch lot and instrument passed qc criteria.The discrepancy reported by the customer was not observed during qc testing.In-house investigation: upon incoming testing of the filmarray torch module, the service technicians discovered labels stuck to the clear sheet covering wells on the mask find image blocking the camera and resulting in false negative results.The reported error was replicated.The wrap-around bladder protection sheet in the instrument was replaced due to obstruction from label.All outgoing testing for the instrument was completed with passing results.Conclusion: the investigation determined that the most probable cause of the discrepant result was a patient label becoming dislodged within the filmarray torch module, obstructing the camera.Analysis of qc and patient run files provided by the customer revealed assay dropouts localized to the area of the array affected by the obstructed view.To prevent this issue, customers are advised to apply patient labels that fit properly within the designated "sample id here" area.Biofire is investigating a potential labeling update to clarify this recommendation and remains committed to continuous product improvement.Clinical performance can be found in biofire bcid2 panel instructions for use (ifu) (www.Online-ifu.Com/iti0048).
Event or Problem Description
Summary: (b)(6) reported potential false negative results on the biofire blood culture identification 2 (bcid2) panel runs on the filmarray torch module (b)(6).No patient harm was reported.The investigation determined that the most probable cause of the discrepant result was a patient label becoming dislodged within the filmarray torch module, obstructing the camera.

• Brand Name: FILMARRAY® TORCH MODULE
• Common Device Name: FILMARRAY® TORCH MODULE
• 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 ; 8017366354
• MDR Report Key: 22879216
• Report Number: 3002773840-2025-00060
• Device Sequence Number: 5776039
• Product Code: NSU
• UDI-Device Identifier: 00815381020277
• UDI-Public: 00815381020277
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: HTFA-SUB-0103
• Device Lot Number: N/A
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown