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

Model Number RFIT-ASY-0147

Device Problem False Negative Result (1225)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

Summary: erlanger medical center (chattanooga, tn) reported a potential false negative enterococcus faecium result on the biofire blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.Due to the biofire bcid2 panel result, the patient was not impacted.The investigation concluded that the most likely cause for the false negative e.Faecium result on the biofire bcid2 panel was a pouch anomaly.

Manufacturer Narrative

Investigation: the patient is an 81 year old male and had signs and symptoms of fistula in the gastrointestinal tract.On (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported enterococcus faecalis as detected.Gram positive chains were observed on gram stain and e.Faecalis and e.Faecium were recovered from culture.The customer reported that due to the biofire bcid2 panel result, the patient was not affected.No serious injury or death was reported.Quality control (qc) records for pouch lot# 32kn23 (kit lot# 2635923) were reviewed.This pouch lot passed qc criteria and was found within specifications.The filmarray instrument (serial number# (b)(6)) was working within designed specifications.Conclusion: the investigation concluded that the most likely cause for the false negative e.Faecium result on the biofire bcid2 panel was a pouch anomaly.Biofire is continuously monitoring the manufacturing process and has controls in place to ensure the 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 on biofire bcid2 panel has a false negative rate of <0.001 in the field over the last year.These rates are within biofire system specifications.According to table 27.Biofire bcid2 panel clinical performance summary, enterococcus spp.Of the biofire bcid2 instructions for use (www.Online-ifu.Com/iti0048), the performance claim for the enterococcus faecium assay showed an overall sensitivity of 100% (95% ci 90.6-100%) and an overall specificity of 99.8% (95% ci 99.4-99.9%).Archived testing was not performed for e.Faecalis or e.Faecium.E.Faecium was detected in all three false positive specimens using an additional molecular method.

• 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: 19147228
• MDR Text Key: 341385470
• Report Number: 3002773840-2024-00305
• 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: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 2635923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2023
• 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: 81 YR
• Patient Sex: Male