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

Model Number	RFIT-ASY-0147
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Summary: the customer (indiana, usa) reported a potential false positive haemophilus influenzae (h.Influenzae) and bacteroides fragilis (b.Fragilis), and false negative streptococcus spp.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, the patient was indirectly impacted, specifically by a delay in appropriate treatment for approximately two days, which might lead to serious injury if it were to recur.No patient harm was reported.The investigation concluded that the most likely cause of the false positive h.Influenzae and b.Fragilis results and false negative streptococcus spp.Results was sensitivity/specificity differences between the biofire bcid2 panel and culture while testing polymicrobial samples.
Event or Problem Description
Summary: the customer (indiana, usa) reported a potential false positive haemophilus influenzae (h.Influenzae) and bacteroides fragilis (b.Fragilis), and false negative streptococcus spp.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, the patient was indirectly impacted, specifically by a delay in appropriate treatment, which might lead to serious injury if it were to recur.No patient harm was reported.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.
Additional Manufacturer Narrative
Investigation: (b)(6) hospital (b)(6) reported a potential false positive haemophilus influenzae (h.Influenzae) and bacteroides fragilis (b.Fragilis), and false negative streptococcus spp.Result on the biofire® blood culture identification 2 (bcid2) panel after testing positive blood culture samples from a 57-year-old female patient.The patient's signs/symptoms at the time of testing were pancreatic pain, vomiting, hypotension, and tachycardia.On (b)(6) 2026, two positive blood culture samples (aerobic and anaerobic blood culture bottles) were tested on the bcid2 panel.In both instances, the bcid2 panel reported h.Influenzae, b.Fragilis, enterobacterales, e.Coli, and k.Pneumoniae as detected, and streptococcus spp.As not detected.It is unknown if the bcid2 product was concordant with the clinical picture.On (b)(6) 2026, using the same samples, k.Pneumoniae, e.Coli, and s.Anginosus were identified in culture with vitek 2.On an unknown date, gram stain detected gram-negative bacilli in the same samples.The bcid2 panel was partially discordant with comparator methods.The customer reported that due to the bcid2 panel results, the patient was indirectly impacted, specifically by a delay in appropriate treatment for approximately two days, which might lead to serious injury if it were to recur.No patient harm was reported.The final diagnosis is septic shock and gram-negative bacteremia.The analysis of the bcid2 run files provided by the customer showed late signatures for the streptococcus spp.And b.Fragilis targets, suggesting the target nucleic acid was present at low levels in the samples, and moderate signatures for the h.Influenzae target, suggesting the target nucleic acid was present in the samples at levels that would be expected to be reproducible.Qc records for bcid2 panel kit lot 0844026 and filmarray instruments tm00611 and tm11905 were reviewed.This kit lot passed qc criteria.The filmarray instruments passed qc and were working within design specifications.Conclusion: the investigation concluded that the most likely cause of the false positive h.Influenzae and b.Fragilis results and false negative streptococcus spp.Results was sensitivity/specificity differences between the biofire bcid2 panel and culture while testing polymicrobial samples.The bcid2 panel runs performed using both the positive aerobic and anaerobic blood culture bottles were analyzed.The h.Influenzae assay showed moderate activity in both runs, suggesting the target nucleic acid was present at levels expected to be reproducible between bcid2 panel runs.The bfragilis assay showed late activity in both runs, indicating nucleic acid was present at low levels for the target of the assay in both samples.The streptococcus assay showed late activity below the threshold for positivity in the assay in both runs.Due to the high sensitivity/specificity of the biofire bcid2 panel and its ability 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 are rare, but can occur and are a part of normal system performance.Standard subculture methods may not identify all organisms in a mixed culture, depending upon the concentration and growth characteristics of each organism present.Fast-growing organisms may outgrow slow-growing organisms, such that standard culture and microbiological identification systems might isolate and identify the fast-growing organisms when the slow-growing organisms may also have been present in the original samples.Discrepancies may also be caused by the inability to reliably differentiate organisms based on standard phenotypic microbial identification methods.It is possible that h.Influenzae and b.Fragilis were present in the samples and were unable to be isolated in culture.For the false negative streptococcus spp.Results, the presence of multiple other organisms in the sample likely drove the blood culture bottle to positivity before streptococcus could reach a detectable level for the bcid2 panel.In polymicrobial blood cultures, the bcid2 panel may not identify all targeted organisms due to varying growth rates that impact the concentration of each target present at bottle positivity.Pcr-based molecular tests are generally more sensitive than culture-based methods of identification.While culture results require viable organism and appropriate growth conditions, the bcid2 panel reports detections of nucleic acid/organism from the sample itself, independent of organism viability.Even if an organism is viable, it is possible for that organism to be present at a level that culture may not detect.The biofire® blood culture identification 2 (bcid2) panel is a multiplexed nucleic acid test designed for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids, along with select genetic determinants associated with antimicrobial resistance.Test results may also be affected by concurrent antibacterial/antifungal therapy or levels of organism in the sample that are below the limit of detection for the test (especially in the case of mixed cultures).All identification results provided by the bcid2 panel are intended to be interpreted in conjunction with gram stain results, clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Clinical performance: clinical performance can be found in tables 30, 32, and 34 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: 50542223
• Report Number: 3002773840-2026-00058
• Device Sequence Number: 10266120
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 09/30/2026

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: 0844026
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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 Age: 57 YR
• Patient Sex: Female