MAUDE Adverse Event Report: BioFire Diagnostics, LLC FILMARRAY ME PANEL

Model Number	RFIT-ASY-0118
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Summary: \ \ (b)(6) \"[spain]\" reported a potential false positive s.Pneumoniae result on the filmarray® meningitis/encephalitis (me) panel after testing a cerebrospinal fluid sample from lumbar puncture.The customer reported that due to the me panel result, that patient was indirectly impacted, since it led to the prolongation of empirical antibiotic treatment with third-generation cephalosporins, which might lead to serious injury if it were to recur.No patient harm was reported.\ \ the investigation concluded that the most likely cause of the patient s.Pneumoniae discrepant result was sensitivity/specificity differences between the biofire me panel and the comparator culture with a low-level analyte concentration near the limit of detection (lod) of the biofire me panel, or contamination.
Additional Manufacturer Narrative
Investigation:\ \ (b)(6) \"[spain]\" reported a potential false positive s.Pneumoniae result on the filmarray® meningitis/encephalitis (me) panel after testing a cerebrospinal fluid (csf) sample from lumbar puncture from a 16-day-old neonate.\ \ on (b)(6)2026, a csf sample was received by the customer and tested on the me panel, which reported streptococcus pneumoniae and enterovirus as detected.The customer reported the positive biofire me panel results to the physician.Confirmatory testing with bacterial culture did not isolate s.Pneumoniae.The sample was retested with the biofire me panel on (b)(6) 2026, which indicated positive results for enterovirus and negative results for s.Pneumoniae.The first me panel result was discordant with comparator method and the second me panel result.\ \ the customer reported that due to the me panel result, that patient was indirectly impacted, since it led to the prolongation of empirical antibiotic treatment with third-generation cephalosporins for an additional 48-hours, which might lead to serious injury if it were to recur.The patient's final diagnosis was enteroviral meningitis and urinary tract infection caused by citrobacter spp.No patient harm was reported.\ \ the run files provided by the customer were analyzed.In the initial biofire me panel run, the me-s.Pneumoniae assay exhibited a late signature.Late signatures can indicate low-level nucleic acid in the sample.\ \ qc records for the kit lot #2412125/pouch lot #3x9e25 and instruments were reviewed.All qc metrics for the pouch/kit lot and instruments were met and passed.The discrepancy reported by the customer was not observed during the qc testing of this pouch/kit lot and no malfunction was observed.The biofire product is performing within specification.\ \ conclusions:\ \ the investigation concluded that the most likely cause of the patient s.Pneumoniae discrepant result was sensitivity/specificity differences between the biofire me panel and the comparator culture with a low-level analyte concentration near the limit of detection (lod) of the biofire me panel, or contamination.\ \ the run files provided by the customer were analyzed.In the initial biofire me panel run, the me-s.Pneumoniae assay exhibited a late signature.In the repeated biofire me panel run, the me-s.Pneumoniae assays exhibited a flat line signature.Confirmatory testing with bacterial culture did not isolate s.Pneumoniae.It is likely that s.Pneumoniae was present in the patient sample at a low level not detected by the comparator culture testing.The detection of an organism or its nucleic acid with a low concentration in the sample can vary from pouch to pouch, and a biofire® filmarray® analyte near the lod concentration in the sample may not always be detected upon retesting.\ \ sensitivity/specificity differences:\ the biofire® me panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test capable of bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (csf) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.Culture requires viable organisms for growth and subsequent testing; however, nucleic acid may persist in vivo independently of organism viability and/or active infection.\ \ due to the high sensitivity/specificity of the panel and the ability of the biofire® filmarray® to detect all organism targets directly from the sample rather than isolated colonies from culture, discrepancies with standard microbial identification and susceptibility techniques can occur and are a part of normal system performance.The detection of organism targets does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms and is dependent upon proper handling, storage, and preparation of the sample.\ \ contamination:\ contamination events often present with late pcr signatures and are difficult to distinguish from true low-level detections.Therefore, it is possible that the detections could be due to low-level contamination.Due to the sensitive nature of the biofire me panel, there is a risk of false positive results from the introduction of exogenous organisms or nucleic acids.While the pouch loading instructions and recommended cleaning steps are sufficient to eliminate contamination the vast majority of the time, it is possible that some microbes/nucleic acids could be introduced during any part of the testing process.Nucleic acids can be introduced into the sample by the laboratory environment, equipment such as pipettes, pipette tips, etc., or personnel handling the sample.\ \ clinical performance:\ clinical performance can be found in tables 9 and 16 of the me panel instruction booklet (www.Online-ifu.Com/iti0035).

• Brand Name: FILMARRAY ME PANEL
• Common Device Name: FILMARRAY ME PANEL
• 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: 50699610
• Report Number: 3002773840-2026-00064
• Device Sequence Number: 14931534
• Product Code: PLO
• UDI-Device Identifier: 00815381020123
• UDI-Public: 00815381020123
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K160462
• 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): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RFIT-ASY-0118
• Device Lot Number: 2412125
• 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: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown