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

Model Number RFIT-ASY-0147

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the patient was a 75-year-old male who presented with signs and symptoms of fever at the time of testing.On (b)(6) 2023, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported all analytes as not detected.On (b)(6) 2023, the same sample was retested on the biofire bcid2 panel.The biofire bcid2 panel reported e.Faecium and candida tropicalis as detected.The customer stated gram-positive cocci were observed on gram stain and the organism was identified as e.Faecium via bd phoenix¿.Only the e.Faecium result was reported to the physician.The customer stated that the patient was not affected or harmed due to the discrepant biofire bcid2 panel results.The final diagnosis of the patient was bloodstream infection.No serious injury or death occurred.Quality control (qc) records for biofire bcid2 panel pouch lots# 2yj923 & 2yxw23 (kit lots# 1893423 & 1950923) were reviewed.These pouch lots passed qc criteria and were found within specifications.The filmarray instrument (serial number# tm11774) was working within designed specifications.Conclusion: the investigation determined that the most likely cause of the discrepant e.Faecium result was a pouch anomaly.Biofire is continuously monitoring the manufacturing process and has controls in place to ensure product is manufactured to the highest quality.Each biofire reagent lot is qualified prior to product release; this qualification includes a high statistical-confidence sampling to confirm that the kit components released for customer use are conforming.All qc metrics for the pouch lot and instrument were met, and they passed qc.Review of the associated instrument showed the instrument was performing within specification and was not expected to have contributed to the discrepancies observed by the customer.Overall, e.Faecium has a false negative rate of <0.001 in the field over the last year.These rates are within biofire system specifications.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 performances: (b)(4).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 pane note: sections d4 and h4 include information for the initial biofire bcid2 panel test (lot# 1893423).The lot number for the second biofire bcid2 panel test was 1950923, with an expiration date of 08/05/2024, and device manufacturer date of 08/13/2023.

Event Description

Summary: tokyo metropolitan tama-hokubu medical center (tokyo, japan) reported two discrepant results on the biofire blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.A potential false negative enterococcus faecium result was reported for the initial biofire bcid2 panel test.A potential false positive candida tropicalis result was reported for the second biofire bcid2 panel test.The patient was not affected or harmed due to the discrepant biofire bcid2 panel results.The investigation determined that the most likely cause of the discrepant e.Faecium result was a pouch anomaly.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: 18619410
• MDR Text Key: 334659510
• Report Number: 3002773840-2024-00213
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

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
• Device Operator: Health Professional
• Device Model Number: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 1893423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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: 75 YR
• Patient Sex: Male