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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: patient information such as sigs/symptoms, age, sex, and final diagnosis were requested from the customer but not provided.One(b)(6) 2026, a periprosthetic tissue specimen was tested with on the biofire joint infection (ji) panel.The ji panel reported s.Aureus as detected.On an unknown date, aerobic and anerobic culture were performed and were both negative.The ji panel was discordant with comparator methods.The customer reported the patient was affected due to likely being misclassified.No patient harm was reported.The analysis of the ji panel run file 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.Conclusion: during the investigation it was determined that the customer was testing an off-label sample type.The customer reported they were using periprosthetic tissue samples on the ji panel which is considered off-label use.The performance of this test has only been validated with synovial fluid collected according to standard technique.The customer reported these results following receipt of field safety corrective action, fa-twd-000074, which identified an increased risk of false positive s.Aureus on kit/pouch lot 0878825/(b)(6).Thus, a likely cause of discrepant results was due to contamination during manufacturing.Alternatively, due to the high sensitivity of the biofire ji panel and the ability of the biofire ji panel to detect all organism targets directly from the patient's sample rather than isolated colonies from culture, discrepancies with standard phenotypic microbial identification and susceptibility techniques can occur and are a part of normal system performance, especially in instances of low-level organism.Due to the sensitive nature of the ji panel, there is a risk of false positive results from the introduction of exogenous organism or nucleic acid.While the pouch loading instructions and recommended cleaning steps are sufficient to eliminate contamination the majority of the time, it is possible that some organism/nucleic acid could be introduced during any part of the testing and pouch handling process.Contamination can also be introduced via the laboratory environment and equipment such as pipettes, pipette tips, etc., or personnel handling the sample.Careful adherence to the sample processing steps described in the instructions for use [rfit-prt-0690] and contamination prevention and decontamination technical note [flm1-prt-0230] is recommended to avoid possible contamination.The customer is advised to follow the instructions in the field safety correction action customer letter and destroy any remaining unused product from the biofire ji kit/pouch lot 0878825/(b)(6).Clinical performance can be found in tables 20, 22, 29-30, 49, and 50 of the biofire® joint infection (ji) panel instructions for use.
Event or Problem Description
The customer (poland) reported a potential false positive staphylococcus aureus result on the biofire joint infection panel after testing a periprosthetic tissue sample.Note, this sample type is considered off-label use.The customer reported the patient was affected due to excessive antibiotic treatment.The customer did not consider the treatment inappropriate but noted that it was excessive.The customer reported there was no deterioration in health due to the treatment at this time.A potential product malfunction was identified.During the investigation it was determined that the customer was testing an off-label sample type.However, the customer reported these results following receipt of field safety corrective action, fa-twd-000074, which identified an increased risk of false positive s.Aureus on kit/pouch lot 0878825/(b)(6).

• 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: 25318403
• Report Number: 3002773840-2026-00015
• Device Sequence Number: 5368620
• Product Code: QSN
• UDI-Device Identifier: 00815381020192
• UDI-Public: 00815381020192
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/18/2026

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: 04/28/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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