MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE JOINT INFECTION (JI) 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	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the (b)(6) medical center, (b)(6) reported a potential false-positive s.Aureus result on the biofire joint infection (ji) panel during patient testing.The patient is a 46-year-old female who presented with right knee swelling at the time of testing.On (b)(6) 2025, synovial fluid was collected from the patient and tested on the ji panel.On (b)(6) 2025, the ji panel reported a 'detected' result for s.Aureus.Culture yielded no growth after four days, and no organism was seen on gram stain.On (b)(6) 2025, repeat testing was performed using the ji panel, and a 'not detected' result for all analytes was reported.The results reported to the physician were s.Aureus detected.The patient was not negatively impacted by the result and was discharged with medicine.No patient harm was reported.The patient's final diagnosis was right knee effusion.The analysis of the ji panel run files provided by the customer showed late or no amplification suggesting that the target nucleic acid was present at low levels.A potential product malfunction was identified.An in-house investigation was performed on the ji panel pouch lot and concluded potential reagent pouch contamination during manufacturing of the lot.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 instructions for use (https://www.Biofiredx.Qarad.Eifu.Online/iti/us/en/all?keycode=iti0017).
Event or Problem Description
The customer (usa) reported a potential false positive staphylococcus aureus result on the biofire joint infection panel after testing a patient sample.The customer reported the patient was not impacted.No patient harm was reported.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 (JI) PANEL
• Common Device Name: BIOFIRE JOINT INFECTION (JI) 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: 24760769
• Report Number: 3002773840-2026-00005
• Device Sequence Number: 18718405
• Product Code: QSN
• UDI-Device Identifier: 00815381020192
• UDI-Public: 00815381020192
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: 46 YR
• Patient Sex: Female