MAUDE Adverse Event Report: BioFire Diagnostics, LLC FILMARRAY TORCH MODULE

Model Number	HTFA-SUB-0103
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) hospital ((b)(6) md) reported potential false positive coronavirus hku1 and parainfluenza virus 4 results on filmarray® torch module (b)(6) after testing the patient¿s nasopharyngeal (np) sample with the biofire® respiratory panel 2.1 panel.No patient harm was reported.A potential product malfunction was identified.Torch module (b)(6) was returned for the investigation.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.

• 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 ; +1(385)770-1328
• MDR Report Key: 50449976
• Report Number: 3002773840-2026-00052
• Device Sequence Number: 21442790
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: HTFA-SUB-0103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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