MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY TORCH SYSTEM BASE

Model Number	HTFA-ASY-0104
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: ((b)(6 )brazil) reported a burning smell coming from the filmarray torch system base over a period of several days.The images provided by the customer show that the power cord appears to have burned/melted at the point of contact with the filmarray torch system base.The customer reported that there was no impact on users or patients.Biofire is currently investigating this event.The full investigation and associated conclusions will be provided in the final report.
Event or Problem Description
Summary: ((b)(6) brazil) reported a burning smell coming from the filmarray torch system base over a period of several days.The images provided by the customer show that the power cord appears to have burned/melted at the point of contact with the filmarray torch system base.The customer reported that there was no impact on users or patients.Biofire is currently investigating this event.The full investigation and associated conclusions will be provided in the final report.
Additional Manufacturer Narrative
Investigation: the customer reported a burning smell coming from the filmarray torch system base over a period of several days.The images provided by the customer show that the power cord appears to have burned/melted at the point of contact with the filmarray torch system base and one of the pins had come loose.The customer reported that there was no impact on users or patients.The filmarray torch system base had one filmarray torch module ((b)(6)) attached and was connected to a ups, with no other equipment sharing the connection.The field application specialist (fas) confirmed that the filmarray torch module ((b)(6)) was functioning normally.A work order (wo) was issued for filmarray torch system base ((b)(6)).However, the fas reported that due to the local bureaucracy in brazil, shipment of the filmarray torch system base could not proceed at this time, rendering the wo unnecessary for now.The investigation will be closed temporarily and reopened once filmarray torch system base becomes available for shipment back for service.The impacted filmarray torch system base was replaced, while the filmarray torch module ((b)(6)) remained at the customer site as no issues were found.Conclusion: due to the limited information currently available, a root cause could not be established.The photographs provided by the customer indicate that an instrument malfunction has occurred, as evidenced by the damage to the power cable.While this visual documentation supports the conclusion of a hardware failure, a definitive root cause could not be assigned at this stage due to limited available data.The investigation will be reopened upon receipt of filmarray torch system base ((b)(6)) for service.A comprehensive evaluation will then be conducted to determine the root cause of the instrument malfunction.
Event or Problem Description
Summary: (b)(6), (brazil) reported a burning smell coming from the filmarray torch system base over a period of several days.The images provided by the customer show that the power cord appears to have burned/melted at the point of contact with the filmarray torch system base.The customer reported that there was no impact on users or patients.Due to the limited information currently available, a root cause could not be established.

• 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 ; 3857701328
• MDR Report Key: 23415490
• Report Number: 3002773840-2025-00076
• Device Sequence Number: 21089621
• 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): 11/20/2025

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-ASY-0104
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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