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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: (b)(6) ((b)(6) france) reported a potential false-positive neisseria meningitidis result on the filmarray® meningitis/encephalitis (me) panel after testing a patient csf sample.A 4-month-old infant presented with pyelonephritis associated with an episode of malaise and poor tolerance of fever.On (b)(6) 2025, at 21:54, the patient's csf sample was collected via lumbar puncture.Cerebrospinal fluid cytology and biochemistry were normal.On (b)(6) 2025, the me panel reported a 'detection' for n.Meningitidis.On an unknown date, the sample was tested on an elitech meningitis pcr kit which resulted as negative.The customer reported the patient was affected due to prolonged iv treatment (inappropriate treatment).No patient harm was reported.The analysis of the me panel run file provided by the customer showed unusual activity across the array, with two melts of the n.Meningitidis assay shifted from the center of the target melt window.A potential product malfunction was identified.An in-house investigation was performed on the module tm08944 instrument and concluded various parts could have contributed to the result observed in customer's site.However, the instrument could not be definitively identified as the root cause of the false positive.Quality control (qc) records for me panel pouch lot# 3suy25 (kit lot# 1047725) and the filmarray torch instrument (serial number# (b)(6)) were reviewed.The pouch lot and instrument passed qc criteria.The discrepancy reported by the customer was not observed during qc testing.Conclusion: the investigation found that the most likely cause of the discrepant result was a possible instrument error or pouch error but was unable to identify a root cause.Module tm08944 was received for work order (b)(4) on (b)(6) 2026.While service was unable to replicate the error observed at the customer site during their in-house testing, they did report that various parts were replaced, including a molded window bladder and cables.Subject matter experts reviewing the service reports of work order (b)(4) also indicated that optic-return issues in the instrument may have contributed to the result observed in the run file provided; however, a similar phenotype may also be seen from pouch plastics.The investigation found that the false positive result was likely due to either an instrument error or pouch manufacturing error but was unable to definitively link cause to either possibility.There are multiple potential sources or causes of false positive and/or false negative results.It is important that all me panel test results be interpreted in conjunction with other clinical, epidemiological, or laboratory information.Clinical performance can be found in tables 9, 14, and 15 of the biofire me panel instructions for use.
Event or Problem Description
(b)(6) ((b)(6), france) reported a potential false-positive neisseria meningitidis result on the filmarray® meningitis/encephalitis (me) panel after testing a patient csf sample.The customer reported that due to the me panel the patient was affected due to prolonged treatment (inappropriate treatment).No patient harm was reported.A potential product malfunction was identified.The investigation found that the most likely cause of the discrepant result was a possible instrument error or pouch error.

• 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 ; 3857701328
• MDR Report Key: 25044907
• Report Number: 3002773840-2026-00009
• Device Sequence Number: 10369622
• Product Code: NSU
• UDI-Device Identifier: 00815381020277
• UDI-Public: 00815381020277
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/30/2026

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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 Age: 4 MO
• Patient Sex: Unknown