MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL

Model Number	RFIT-ASY-0116
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: two potential false positive vibrio and v.Cholera results on the biofire gi panel was reported after testing a patient stool sample in cary blair media on (b)(6) 2024.The patient was not impacted due to the biofire gi panel results as it 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 vibrio and v.Cholera results was the presence of non-viable organism/nucleic acid in the cary blair transport media.While cary blair medium vials are autoclaved and routinely quality controlled for sterility, non-viable organisms or nucleic acids can remain in the transport medium after the sterilization process.The presence of non-viable organisms and nucleic acid does not compromise the intended use of transport medium, transportation and preservation of clinical stool and rectal specimens; however, the biofire gi panel does not distinguish between nucleic acid from viable or non-viable organisms.The "laboratory precaution" and "limitation" sections of the filmarray gi reagent instruction booklet ((b)(6)) outlines the potential for false positive detections during molecular testing with sterile cary blair transport medium containing detectable levels of non-viable organisms and/or nucleic acid.Importantly, results from the biofire gi panel are intended to be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Detection of organism targets does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms.Clinical performance: according to table 11.Biofire gi clinical performance summary of the filmarray gi reagent instruction booklet, the performance claim for vibrio (v.Parahaemolyticus/v.Vulnificus/v.Cholerae) compared to stool culture with standard manual/automated microbiological/biochemical identification showed a specificity of 99.9% (95% ci 99.5-100%).Vibrio was detected in 2/2 false positive specimens using bi-directional sequence analysis.To supplement the results of the prospective clinical study, an evaluation of preselected archived specimens was performed.According to table 17.Biofrie gi panel archived specimen performance data summary, the performance claim for vibrio showed a positive percent agreement (ppa) of 100% (95% ci n/a) and a negative percent agreement (npa) of 100% (95% ci 97.1-100%).Additionally, in table 18.Biofire gi panel performance using contrived specimens, vibrio showed a ppa of 97.4% (95% ci 926-99.5%) and a npa of 100% (95% ci 94.0-100%).Includes 64/65 v.Cholerae (five different strains were used in spiking; one specimen spiked near the assay limit of detection was not detected) and 48/50 non-v.Cholerae (four v.Parahaemolyticus strains and one v.Vulnificus strain were used in spiking; two specimens spiked with v.Parahaemolyticus near the assay limit of detection were not detected).According to table 11.Biofire gi clinical performance summary of the filmarray gi reagent instruction booklet, the performance claim for the v.Cholerae assay compared to stool culture with standard manual/automated microbiological/biochemical identification showed a specificity of 99.9% (95% ci 99.6-100%).V.Cholerae was detected in the single false positive specimen using bi-directional sequence analysis.To supplement the prospective data, an evaluation of contrived specimens was performed.According to table 18.Biofire gi panel performance using contrived specimens of the filmarray gi reagent instruction booklet, the performance claim for v.Cholerae showed a positive percent agreement (ppa) of 84.6% (95% ci 73.5-92.4%) and a negative percent agreement (npa) of 100% (95% ci 96.7-100%).Ten of the contrived specimens were spiked with an isolate which was found to have a highly divergent toxr gene that was not present in the ncbi database and non-reactive with the biofire gi panel v.Cholerae assay.The biofire gi panel vibrio assay was positive for nine of these specimens.
Event or Problem Description
Summary: (b)(6) hospital ((b)(6)) reported two potential false positive vibrio and vibrio cholera results on the biofire® filmarray® gastrointestinal (gi) panel after testing a patient stool sample.The patient was not impacted due to the biofire gi panel results as it was not reported to the physician.The investigation determined that the most likely cause of the discrepant results was the presence of non-viable organism/nucleic acid in the cary blair transport media.

• Brand Name: BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) PANEL
• Common Device Name: BIOFIRE® FILMARRAY® GASTROINTESTINAL (GI) 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 ; 8017366354
• MDR Report Key: 19635411
• Report Number: 3002773840-2024-00362
• Device Sequence Number: 7137678
• Product Code: PCH
• UDI-Device Identifier: 00815381020109
• UDI-Public: 00815381020109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K230404
• 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): 06/28/2024

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: 11/10/2024
• Device Model Number: RFIT-ASY-0116
• Device Catalogue Number: RFIT-ASY-0116
• Device Lot Number: 2825823
• 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: 06/08/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2023
• 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: 58 YR
• Patient Sex: Female