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	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Summary: (b)(6) hospital (b)(6) (b)(6) reported a potential false positive result on the biofire joint infection panel (ji) panel after testing a patient's synovial fluid (sf).The customer reported that due to the biofire result the patient was treated with anti-staphylococcal antibiotics.The patient¿s condition was most likely attributable to a postoperative hematoma.The antibiotic treatment was maintained empirically due to the tka-related complication.No patient harm was reported.A potential product malfunction was identified.Biofire has requested further information from the customer and is currently investigating this event.Similar events were recently observed in the field, with ji panel kit lots 0878825 and 0883425 having an elevated risk for false positive staphylococcus aureus.A field safety corrective action (fsca) was issued on (b)(6) 2026, via (b)(4).

• 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: 25279365
• Report Number: 3002773840-2026-00012
• Device Sequence Number: 10085477
• Product Code: QSN
• UDI-Device Identifier: 00815381020192
• UDI-Public: 00815381020192
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 06/09/2026

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: 05/11/2026
• Device Model Number: RFIT-ASY-0138
• Device Lot Number: 0883425
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: 77 YR
• Patient Sex: Male