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

Model Number	RFIT-ASY-0144
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer (b)(6) reported a potential false positive coronavirus result on the biofire filmarray® pneumonia panel after testing a patient sample.The patient was not impacted by the result.A potential product malfunction was identified.Biofire has requested further information from the customer and is currently investigating this event.Similar events have been observed in the field with biofire filmarray® pneumonia panel and pneumonia plus panels.A field safety corrective action (fsca) was issued in the u.S.In february 2025 via fsca 5790 to update the panel software.At the time this complaint was received, the customer had not implemented the updated software.

• Brand Name: FILMARRAY PNEUMO PANEL
• Common Device Name: FILMARRAY PNEUMO 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: 50267267
• Report Number: 3002773840-2026-00037
• Device Sequence Number: 16096628
• Product Code: QDP
• UDI-Device Identifier: 00815381020178
• UDI-Public: 00815381020178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243222
• 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): 08/26/2026

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: RFIT-ASY-0144
• Device Lot Number: 0454326
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/16/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2026
• 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
• Patient Age: 84 YR
• Patient Sex: Female