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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Summary: the customer (b)(6) reported a potential false positive varicella zoster virus (vzv) result on the filmarray® meningitis/encephalitis (me) panel after testing a patient csf sample.The customer reported that due to the me panel result, that patient was indirectly impacted, specifically initiation of acyclovir that was likely unnecessary, 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 vzv discrepant result was due to low level contamination.
Event or Problem Description
The customer (dunedin, new zealand) reported a potential false positive varicella zoster virus (vzv) result on the filmarray® meningitis/encephalitis (me) panel after testing a patient csf sample.The customer reported that due to the me panel result, that patient was indirectly impacted, specifically initiation of antibiotic therapy that was likely unnecessary, which might lead to serious injury if it were to recur.No patient harm was reported.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.
Additional Manufacturer Narrative
Investigation: the patient was a 1-day-old male preterm infant with increasing respiratory support needs.On (b)(6) 2026, the patient csf sample was collected via puncture and tested on the biofire filmarray meningitis/encephalitis (me) panel.The me panel reported varicella-zoster virus (vzv) as detected.The me panel was discordant with the clinical picture.On an unknown date, roche lightmix hsv/vzv pcr was performed on the same sample and yielded a negative result for vzv.The me panel was discordant with comparator methods.The customer reported that due to the me panel result, that patient was indirectly impacted, specifically initiation of antibiotic therapy (acyclovir) that was likely unnecessary, which might lead to serious injury if it were to recur.No patient harm was reported.The analysis of the me panel run file provided showed by the customer showed a late signature suggesting that the target nucleic acid was present at low levels.Quality control (qc) records for me panel pouch lot# 3va625 (kit lot# 1696125) and the instrument (serial number# 2fa00007) 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 concluded that the most likely cause of the vzv discrepant result was due to low level contamination.Due to the sensitive nature of the me panel, there is a risk of false positive results from the introduction of exogenous organism or nucleic acid.While the pouch loading instructions and recommended cleaning steps are sufficient to eliminate contamination the majority of the time, it is possible that some organism/nucleic acid could be introduced during any part of the testing and pouch handling process.Contamination can also be introduced via the laboratory environment and equipment such as pipettes, pipette tips, etc., or personnel handling the sample.Clinical performance can be found in tables 9 and 14 of the biofire® me panel ifu (https://www.Biofiredx.Qarad.Eifu.Online/iti/all?keycode=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: 50570510
• Report Number: 3002773840-2026-00061
• Device Sequence Number: 9891181
• Product Code: PLO
• UDI-Device Identifier: 00815381020123
• UDI-Public: 00815381020123
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 09/30/2026

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 Expiration Date: 09/22/2026
• Device Model Number: RFIT-ASY-0118
• Device Lot Number: 1696125
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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: Male