MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (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	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a potential false positive s.Marcescens result on the biofire bcid2 panel was reported after testing a patient blood culture sample on (b)(6) 2025.S.Marcescens was not recovered from culture.The patient was not impacted due to the biofire bcid2 panel result as the positive s.Marcescens result was not reported to the physician.No serious injury or death was reported.Conclusion: the investigation determined that the most likely cause of the discrepant s.Marcescens result was the presence of non-viable organism/nucleic acid in the blood culture media bottle.Similar events were recently observed in the field with the combination of the biofire bcid2 panel and specific lots of bact/alert® culture media bottles.A field safety corrective action (fsca) was issued in the u.S.On june 4, 2024 via fsca fa-twd-000005.Fsca fa-twd-000029, an extension of fsca fa-twd-000005, was issued in the u.S.On january 22, 2025, for this issue.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 biofire bcid2 panel does not distinguish between nucleic acid from viable or non-viable organisms.The "laboratory precaution" and "limitation" sections of the biofire bcid2 panel instructions for use (ifu) (www.Online-ifu.Com/iti0048) outlines the potential for false positive detections during molecular testing with sterile blood culture media containing detectable levels of non-viable organisms and/or nucleic acid.Importantly, results from the biofire bcid2 panel 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 biofire bcid2 panel are intended to be interpreted in conjunction with gram stain results.Clinical performance: according to table 33.Biofire bcid2 panel clinical performance summary, enterobacterales of the biofire bcid2 panel ifu, the performance claim for the s.Marcescens assay compared to standard manual and automated microbiological/biochemical identification methods showed an overall sensitivity of 100% (95% ci 87.5-100%) and an overall specificity of 100% (95% ci 99.7-100%).
Event or Problem Description
Summary: (b)(6) hospital ((b)(6)), reported a potential false positive serratia marcescens result on the biofire blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.The patient was not impacted due to the biofire bcid2 panel result.The investigation determined that the most likely cause of the discrepant s.Marcescens result was the presence of non-viable organism/nucleic acid in the blood culture media bottle.

• Brand Name: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Common Device Name: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (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 ; 8017701328
• MDR Report Key: 22067002
• Report Number: 3002773840-2025-00044
• Device Sequence Number: 9501684
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 05/28/2025
• Device Model Number: RFIT-ASY-0147
• Device Lot Number: 1295224
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2024
• 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