MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

Model Number RFIT-ASY-0147

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

Summary: (b)(6) reported two potential false positive serratia marcescens results on the biofire blood culture identification 2 (bcid2) panel for the same patient after testing the patient's blood culture sample.Due to the biofire bcid2 panel result, the patient was not affected.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.

Manufacturer Narrative

Investigation: two potential false positive serratia marcescens results on the biofire bcid2 panel for the same patient was reported after testing the patient's blood culture sample.Both tests were performed on february 18, 2024.The patient was not affected due to the biofire bcid2 result.The same sample was used for all additional testing.Gram-stain showed gram positive cocci in pairs and clusters.Customer reports culture was done but no results were reported.No serious injury or death 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.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 biofire bcid2 panel is working as intended.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%).

• Brand Name: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Type of Device: 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 ; 8017366354
• MDR Report Key: 18943098
• MDR Text Key: 339219916
• Report Number: 3002773840-2024-00283
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 2561023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male