MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE JOINT INFECTION PANEL

Model Number	RFIT-ASY-0138
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: (b)(6) hospital ((b)(6) spain) reported a potential false positive staphylococcus aureus result on the biofire joint infection (ji) panel after testing a patient's sample.The patient's symptoms/reason for visit was requested and not provided.On (b)(6) 2026, an unknown sample was tested on the biofire ji panel.The ji panel reported s.Aureus as detected.On an unknown date, other unknown methodologies were performed and did not detect s.Aureus.The ji panel was discordant with the comparator method.The customer indicated the s.Aureus result was reported to the clinician and the patient was taken to the surgery room without it being necessary.However, no patient harm was reported.The analysis of the ji panel run file provided by the customer showed late amplification, suggesting that the target nucleic acid was present at low levels.Quality control (qc) records for kit/pouch lot 0878825/3rxz25 and instrument (b)(6) were reviewed.The pouch lot passed qc criteria and was found within specification.The filmarray instrument (serial # (b)(6)) was working within designed specifications.Conclusion: the investigation found that the most likely cause of the discrepant results was due to contamination during manufacturing.Analysis of the customer provided information and in-house investigation of the biofire ji panel pouch lot indicate a potential low-level contamination event during the manufacturing of this lot.Each biofire reagent lot is qualified prior to product release; this qualification includes a high statistical-confidence sampling to confirm that the kit components released for customer use are conforming.All qc metrics for the pouch lot were met, suggesting contamination exists below lod or was limited to a small portion within the lot.Per the ji panel instructions for use [rfit-prt-0690], false positive results can be the result of a variety of sources and causes; it is important that results be used in conjunction with other clinical, epidemiological, or laboratory information.Clinical performance can be found in tables 20, 49, and 50 of the biofire® joint infection (ji) panel instruction booklet.Https://www.Biofiredx.Qarad.Eifu.Online/iti/us/all?keycode=iti0017.
Event or Problem Description
Summary: the customer (barcelona, spain) reported a potential false positive staphylococcus aureus result on the biofire joint infection (ji) panel after testing a patient's sample.The customer indicated the s.Aureus result was reported to the clinician, and the patient was taken to the surgery room without it being necessary.However, no patient harm was reported.A potential product malfunction was identified.The investigation found that the most likely cause of the discrepant results was contamination during manufacturing.

• Brand Name: BIOFIRE JOINT INFECTION PANEL
• Common Device Name: BIOFIRE JOINT INFECTION 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 ; 3857701328
• MDR Report Key: 24760910
• Report Number: 3002773840-2026-00006
• Device Sequence Number: 10299187
• Product Code: QSN
• UDI-Device Identifier: 00815381020192
• UDI-Public: 00815381020192
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: DEN200066
• 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): 04/01/2026

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 Expiration Date: 05/10/2026
• Device Model Number: RFIT-ASY-0138
• Device Lot Number: 0878825
• 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: 03/03/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2025
• 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
• Patient Sex: Unknown