MAUDE Adverse Event Report: BioFire Diagnostics, LLC BIOFIRE BCID2 PANEL

Model Number	RFIT-ASY-0147
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) reported a potential false positive vana/b result on the biofire® blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.The customer reported that due to the bcid2 result, that patient experienced indirect harm, specifically the patient was taken off of vancomycin and was put on 6 weeks of iv daptomycin and ampicillin then moved to linezolid, which might lead to serious injury if it were to recur.No patient harm was reported.The investigation determined that the most likely cause of the discrepant vana/b results was sensitivity/specificity differences between the biofire® bcid2 panel and comparator phenotypic susceptibility methods.
Additional Manufacturer Narrative
Investigation: the patient was a hemodialysis patient who had eight blood culture samples collected across different dates (b)(6) 2026).On (b)(6) 2026, the first, second, and third set of blood cultures were tested on the biofire® blood culture identification 2 (bcid2) panel.The bcid2 panel reported enterococcus faecium and vana/b as detected on 7 runs.On (b)(6) 2026, the fourth set of blood cultures were tested on the bcid2 panel.The bcid2 panel reported enterococcus faecium and vana/b as detected on 2 runs.The result reported to the physician was vana/b detected.On an unspecified date, gram stain, culture, and susceptibility testing were performed.Gram stain yielded gram positive cocci in pairs and chains.Culture was resulted as enterococcus faecium identified via mass spectrometry.Susceptibility testing showed vancomycin as susceptible via vitek ast-gp75 and confirmed via vancomycin etests and vancomycin kirby bauer discs as well.The customer reported that due to the bcid2 results, the patient was taken off of vancomycin and put on iv daptomycin and ampicillin for 6 weeks and then moved to linezolid.The patient was still hospitalized and the customer was unable to provide any additional information regarding patient care.No patient harm was reported.The analysis of the bcid2 panel run files provided by the customer showed robust melt signatures suggesting that the target nucleic acid present at a level that would be expected to be reproducible.Qc records for pouch/kit lot 3xl725/2504225 and instruments tm13299, tm02928, tm19280, tm01342, and tm04391 were reviewed.All qc metrics for the pouch/kit lot and instruments were met and passed.Instruments appeared to be operating as intended.Conclusion: the investigation determined that the most likely cause of the discrepant vana/b results was sensitivity/specificity differences between the biofire® bcid2 panel and comparator phenotypic susceptibility methods.The biofire® blood culture identification 2 (bcid2) panel is a multiplexed nucleic acid test intended for simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance.While rare, discrepancies between biofire and other laboratory methods are part of the normal performance of the product observed in the field.Antimicrobial resistance can occur via multiple mechanisms.A detected result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected.Culture is required to obtain isolates for antimicrobial susceptibility testing, and biofire® bcid2 panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.Due to the high sensitivity/specificity of the biofire bcid2 panel and the ability to detect organisms/antimicrobial resistance genes directly from the patient's blood culture rather than isolated culture colonies, discrepancies with standard identification techniques can occur and are a part of normal system performance.False positive results can be the result of a variety of sources and causes.Detection of organism targets does not imply that the corresponding organisms are infectious or the causative agents for clinical symptoms.Results from this test are intended to be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.All identification results provided by the bcid2 panel are intended to be interpreted in conjunction with gram stain results.Clinical performance can be found in table 81 of the biofire® blood culture identification 2 (bcid2) panel instruction booklet: https://www.Biofiredx.Qarad.Eifu.Online/iti/all?keycode=iti0048.

• Brand Name: BIOFIRE BCID2 PANEL
• Common Device Name: BIOFIRE BCID2 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 ; +1(385)770-1328
• MDR Report Key: 50198045
• Report Number: 3002773840-2026-00031
• Device Sequence Number: 12142874
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K243759
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RFIT-ASY-0147
• Device Lot Number: 2504225
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown