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 Type  malfunction  

Manufacturer Narrative

Investigation: a potential false positive c.Tropicalis result on the biofire bcid2 panel was reported after testing a patient blood culture sample.It is unknown if the patient was impacted due to the biofire bcid2 result.No serious injury or death reported.Conclusion: the investigation determined that the most likely cause of the discrepant c.Tropicalis 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 bd bactec¿ blood culture bottles.A field safety corrective action (fsca) was issued in the u.S.On january 26, 2024, and countries outside u.S.On january 30, 2024, via fsca #5811 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 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 38.Biofire bcid2 panel clinical performance summary, candida spp.Of the biofire bcid2 panel ifu, the performance claim for the c.Tropicalis assay compared to standard of care identification for genus level followed by pcr & sequencing of isolates for species identification showed an overall sensitivity of 100% (95% ci 93.5-100%) and an overall specificity of 99.9% (95% ci 99.7-100%).The single false positive specimen was identified as a cross-reactivity between the biofire bcid2 panel c.Tropicalis assay and high titer candida parapsilosis.This cross-reactivity is a known limitation of the biofire bcid2 panel.

Event Description

Summary: (b)(6) hospital reported a potential false positive candida tropicalis result on the biofire blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.Due to the biofire bcid2 panel result, it is unknown if the patient was impacted.The investigation determined that the most likely cause of the discrepant c.Tropicalis 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
• 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: 18906184
• MDR Text Key: 337748366
• Report Number: 3002773840-2024-00281
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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