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	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: (b)(6) austria) reported a potential false positive staphylococcus aureus result on the biofire® joint infection (ji) panel after testing a biopsy sample from a 47-year-old female patient.The sample type utilized is considered off-label use of the device, therefore, the expected performance of device is unknown.Regardless of off-label use, investigation identified a potential product malfunction.The customer stated that the patient was not harmed due to the ji panel result.The analysis of the discrepant ji panel run file provided showed by the customer showed late signature, suggesting that the target nucleic acid was present at low levels.Qc records for kit/pouch lot 0878825/3rxz25 and instrument 2fa08577 were reviewed.This pouch lot passed qc criteria.The filmarray instrument passed qc and was working within design specifications.Conclusion: the investigation concluded that the most likely cause of the discrepant s.Aureus result at the customer site was due to reagent pouch contamination during manufacturing.Analysis of the run file provided by the customer and in-house investigation of the biofire ji panel pouch lot indicate a potential low-level contamination event during the manufacturing of this lot.Off-label use remains a possible cause of this event; however, a product malfunction could not be ruled out as a possible cause based on the provided run files.False positive and false negative results can be the result of a variety of sources and causes, it is important that these 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 instructions for use (https://www.Biofiredx.Qarad.Eifu.Online/iti/us/en/all?keycode=iti0017).
Event or Problem Description
Summary: the customer (zams, austria) reported a potential false positive staphylococcus aureus result on the biofire® joint infection (ji) panel after testing a patient biopsy sample.The customer reported that there was no impact to the patient due to the ji panel result, and the customer stated the patient was not harmed.The investigation determined that the most likely the cause of the false positive s.Aureus result 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: 24754527
• Report Number: 3002773840-2026-00004
• Device Sequence Number: 8743761
• Product Code: QSN
• UDI-Device Identifier: 00815381020192
• UDI-Public: 00815381020192
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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 Age: 47 YR
• Patient Sex: Female