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	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per biofire medical affairs, it is unlikely that the biofire bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.The authors were using bd bactec blood culture bottles.It is likely that the candida tropicalis result was due to non-viable nucleic acid fragments in the blood culture media; however, biofire¿s investigation into this event is ongoing.The full investigation and associated conclusions will be provided in the final report.Conclusion: n/a for initial report.References: fenlon la, swaminathan n.Masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist.Open forum infect dis.2025 sep 24;12(10):ofaf598.Doi: 10.1093/ofid/ofaf598.Pmid: 41103781; pmcid: pmc12526975.
Event or Problem Description
Summary: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per biofire medical affairs, it is unlikely that the biofire bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.The authors were using bd bactec blood culture bottles.It is likely that the candida tropicalis result was due to non-viable nucleic acid fragments in the blood culture media.
Event or Problem Description
Summary: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per biofire medical affairs, it is unlikely that the biofire bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.The authors were using bd bactec blood culture bottles.It is likely that the candida tropicalis result was due to non-viable nucleic acid fragments in the blood culture media.
Additional Manufacturer Narrative
Investigation: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per biofire medical affairs, it is unlikely that the biofire bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.The authors were using bd bactec blood culture bottles.It is likely that the candida tropicalis result was due to non-viable nucleic acid fragments in the blood culture media; however, biofire¿s investigation into this event is ongoing.The full investigation and associated conclusions will be provided in the final report.Conclusion: n/a for follow-up report.References: fenlon la, swaminathan n.Masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist.Open forum infect dis.2025 sep 24;12(10):ofaf598.Doi: 10.1093/ofid/ofaf598.Pmid: 41103781; pmcid: pmc12526975.Note: corrections to three fields were made between the initial report and this follow-up report.Brand name and common device name fields (d1 and d2a) were updated to omit ", 30 tests".The region state field (e1) was updated from to "ut".
Event or Problem Description
Summary: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per the publication, expedited identification would likely not have changed the outcome given rapid deterioration and multidrug resistance.According to biofire medical affairs, it is unlikely that the biofire bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.The investigation is consistent with the publication's conclusion which determined that the most likely cause for the discrepant result was due to the presence of non-viable organism or nucleic acid fragments in the blood culture media.Because run files were not provided, the timeframe of the testing at issue in the publication is not clear, and authors were using bd bactec blood culture bottles.Thus, it is possible that this event was related to biomérieux's previously active fsca-5811.
Additional Manufacturer Narrative
Investigation: fenlon et al.Published a case study, "masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist¿ from the university of utah hospital (salt lake city, utah) which describes a potential false positive candida tropicalis on the biofire blood culture identification 2 (bcid2) panel during patient testing.The patient was admitted with neutropenic fever to an academic cancer hospital.The patient was febrile to 39.3°c and intermittent wheezing.The patient had refractory acute myeloid leukemia.Before admission, the patient had been taking posaconazole 300 mg daily for antifungal prophylaxis per institutional neutropenia guidelines.The patient had also been treated with once-monthly intravenous pentamidine for pneumocystis prophylaxis, with the last dose given 25 days before admission.There was concern for pjp pneumonia prompting empiric treatment with trimethoprim- sulfamethoxazole (2 double-strength tablets 3 times daily).The timeline of hospitalization and testing is unknown.On hospital day 3, the admission blood cultures, utilizing bd bactec blood culture bottles, yielded a preliminary positive result of yeast identified by gram stain.Two hours later, the blood culture sample was tested on the bcid2 panel and reported candida tropicalis as detected.The lab¿s bcid2 report included a disclaimer: ¿candida tropicalis could be a potential contaminant.Interpret results in conjunction with other clinical symptoms.¿ the publication later stated this result was due to amplification of nonviable dna.Based on this information, the clinical impression was that the patient had invasive candidiasis, potentially complicated by endocarditis with septic emboli to the lungs.Consequently, caspofungin (150-mg loading dose followed by 100 mg daily) was started, and the patient¿s chronic indwelling peripherally inserted central venous catheter was removed as this was considered a potential source.The patient had ongoing high-grade fevers, increasing oxygen requirements, and progressive renal failure.An elevated bal aspergillus galactomannan (index 0.96, positive considered >0.5) from bronchoscopy suggested a concomitant pulmonary mold infection.Posaconazole was stopped due to concern for breakthrough and voriconazole started (6 mg/kg every 12 hours for a 2-dose load followed by 4 mg/kg every 12 hours).An aspergillus species pcr on bal fluid and a pjp pcr were both negative.Three days after the blood culture signaled positive, the blood culture report was corrected from yeast to filamentous fungus, as the organism was identified as lomentospora prolificans on maldi.With this information, terbinafine 500¿mg twice daily was added to voriconazole and caspofungin pending susceptibilities.The lomentospora isolate was later found to be resistant to all commercially available antifungal agents.The bal fungal culture ultimately grew lomentospora as well.The patient continued to deteriorate and via shared decision-making with the primary team and his family, the patient elected to transition to comfort care.The patient died on hospital day 8.The publication stated disseminated lomentospora prolificans is a rare and highly morbid infection.The publication described a multi-faceted clinical presentation and clinical course, which eventually included the patient's deterioration and death.Per the publication, expedited identification would likely not have changed the outcome given rapid deterioration and multidrug resistance.According to biofire medical affairs, it is unlikely that the bcid2 panel results caused or contributed to the patient's death; however, a potential product malfunction was identified.Run files were not requested, so they could not be analyzed, and qc information for the pouch lot and instrument could not be reviewed.Conclusion: the medical affairs assessment is consistent with the publication's conclusion that the biofire result did not contribute to the patient's death.The investigation is consistent with the publication's conclusion which determined that the most likely cause for the discrepant result was the presence of non-viable organism or nucleic acid fragments in the blood culture media.Because run files were not provided, the timeframe of the testing at issue in the publication is not clear, and authors were using bd bactec blood culture bottles.Thus, it is possible that this event was related to biomérieux's previously active fsca-5811.While blood culture vials are autoclaved and routinely quality controlled for sterility, non-viable organisms or nucleic acids can remain in the blood culture media after the sterilization process.The presence of non-viable organisms and nucleic acid does not compromise the intended use of blood culture media, culturing viable microorganisms; however, the bcid2 panel does not distinguish between nucleic acid from viable or non-viable organisms.The biofire® blood culture identification 2 (bcid2) panel instruction booklet [rfit-prt-0841] contains a laboratory precaution and a limitation outlining potential false positive detection during molecular testing on media containing detectable levels of nucleic acid: "blood culture media may contain non-viable organisms and/or nucleic acids at levels that can be detected by the bcid2 panel.¿ customers are recommended to contact bd and notify them of this discrepancy.¿the presence of non-viable organisms and/or nucleic acids in blood culture media may lead to false positive test results.Increases in false positive results due to non-viable acinetobacter, p.Aeruginosa, proteus and e.Coli have been previously identified in various media types; the organism involved and frequency of such occurrences may change in the future.Typically, these false positives present with more than one positive result because the bcid2 panel may also detect the organism that is growing in the culture bottle.¿ importantly, 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.It should be noted that as run files were not requested for this complaint, there exists a possibility that the reported c.Tropicalis result could be a true detection.Discrepancies with culture may exist if c.Tropicalis is ¿detected¿ and is present at levels that could be missed through standard culture.Clinical performance can be found in table 38 of the biofire® blood culture identification 2 (bcid2) panel instruction booklet (https://www.Biofiredx.Qarad.Eifu.Online/iti/all?keycode=iti0048).References: fenlon la, swaminathan n.Masquerading yeast: a case report of lomentospora prolificans fungemia with a diagnostic twist.Open forum infect dis.2025 sep 24;12(10):ofaf598.Doi: 10.1093/ofid/ofaf598.Pmid: 41103781; pmcid: pmc12526975.

• 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 84108
• Manufacturer Contact: 515 colorow dr; salt lake city, UT 84108 ; 3857701328
• MDR Report Key: 23535109
• Report Number: 3002773840-2025-00078
• Device Sequence Number: 21374196
• Product Code: PEN
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K243759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2026

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 Model Number: RFIT-ASY-0147
• Device Lot Number: N/A
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 10/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Male