MAUDE Adverse Event Report: BioFire Diagnostics, LLC FILMARRAY TORCH SYSTEM BASE

Model Number	HTFA-ASY-0104
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Summary: (b)(6) reported a burnt power entry module on biofire® filmarray® torch base (b)(6).During troubleshooting, a burnt power entry module and cable were noticed.The images provided by the customer confirm reported issue of burnt prongs on the torch base.The customer confirmed no harm or injury to the operator.A potential product malfunction was identified.Torch base (b)(6) has been requested to be returned for the investigation and attempts for the instrument's return are still ongoing.Update for follow up report: biofire is still investigating this event in order to determine the root cause.The full investigation and associated conclusions will be provided in the final supplemental report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.

• Brand Name: FILMARRAY TORCH SYSTEM BASE
• Common Device Name: FILMARRAY TORCH SYSTEM BASE
• 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: 50408512
• Report Number: 3002773840-2026-00045
• Device Sequence Number: 10621998
• Product Code: NSU
• UDI-Device Identifier: 00815381020253
• UDI-Public: 00815381020253
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/22/2026

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-ASY-0104
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/19/2024
• 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