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

Model Number RIFT-ASY-0147

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

Summary: (b)(6) hospital (greensboro, nc) reported a potential false negative ctx-m result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's blood culture sample.Due to the biofire bcid2 panel result, the patient's antibiotic treatment was delayed.No serious injury or death was reported.The investigation concluded that multiple potential causative factors may have contributed to the discrepancies the customer experienced.These include but are not limited to, array fill issues or fluid movement issues.

Manufacturer Narrative

Investigation: the patient was a 73-year-old female.On (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported enterobacterales and escherichia coli as detected.On the same day, gram-negative rods were observed on gram stain and e.Coli was recovered from culture.On (b)(6) 2024, susceptibility testing showed extended spectrum beta-lactamase (esbl).On (b)(6) 2024, a repeat susceptibility testing showed esbl, and the pharmacy was notified of this result.The customer also stated that a second biofire bcid2 panel test was performed after 24 hours of the initial test and the biofire bcid2 panel detected e.Coli and ctx-m.The customer reported that due to the biofire bcid2 panel result, the patient's antibiotic treatment was delayed.It is unknown if the patient was impacted due to this delay.The final diagnosis of the patient was severe sepsis and acute cystitis without hematuria.No serious injury or death was reported.Conclusion: the investigation concluded that multiple potential causative factors may have contributed to the discrepancies the customer experienced.These include but are not limited to, array fill issues or fluid movement issues.A review of the biofire bcid2 panel run file provided by the customer revealed assay replicate failures of ctx-m, pcr2 control, and dna process control.In the principle of the procedure section of the biofire bcid2 panel instructions for use (ifu) (www.Online-ifu.Com/iti0048), the operations and processes that occur during a biofire bcid2 panel run are described.As second stage pcr takes place, the products from the first stage pcr are diluted and mixed with fresh pcr reagents, and the solution is distributed over the 2nd stage pcr array.The individual wells of the array contain the primers for different assay targets, and dna melting analysis interprets the reactions during 2nd stage pcr.In rare occurrences, such as those experienced by the customer, there may be a failure for the array to fill, causing a false interpretation.The array fill issues may have been due to instrument tm02372 failing to move fluid properly, biofire work order (b)(4) found several parts needing cleaning, replacement, and/or recalibration.A review of manufacturing and qc records for pouch/kit lot 31w423/2503423 did not reveal similar anomalies, indicating the product was manufactured and performing within specification.Additionally, no similar complaints from other customers have been reported for this pouch/kit lot.Biofire continuously monitors the manufacturing process and has controls in place to ensure the product is manufactured to the highest quality.Our quality control measures screen for pouch manufacturing defects from a high confidence statistical sampling of each lot of reagents and other kit components.The pouch lot passed all qc metrics indicating that it was manufactured within specification.According to table 44.Biofire bcid2 panel clinical performance summary, ctx-m of the biofire bcid2 panel instructions for use (www.Online-ifu.Com/iti0048), the performance claim of the ctx-m assays compared to pcr/sequencing with any associated organism showed an overall positive percent agreement of 99.1 % (95% ci 95.0-99.8%) and an overall negative percent agreement of 100% (95% ci 99.3-100%).

• 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: 19149500
• MDR Text Key: 340689151
• Report Number: 3002773840-2024-00310
• 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: RIFT-ASY-0147
• Device Catalogue Number: RIFT-ASY-0147
• Device Lot Number: 2503423
• 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: 10/14/2023
• 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: 73 YR
• Patient Sex: Female