MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® 2.0 INSTRUMENT

Model Number	FLM2-ASY-0001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the patient was a 5-year-old male with signs/symptoms of sepsis.On (b)(6) 2024, the patient's blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported all analytes as not detected.Note that the customer used a biofire bcid2 panel pouch with an expiration date of december 4, 2024.Gram negative rods were observed on gram stain.P.Aeruginosa was recovered from culture, which was identified via maldi-tof.On (b)(6) 2024, the patient's blood culture sample was tested again on the biofire bcid2 panel (the same pouch lot used in the (b)(6) 2024, test was used).The biofire bcid2 panel reported p.Aeruginosa as detected.Please note that the customer used an expired biofire bcid2 panel pouch for this test.This is considered an off-label use of the biofire bcid2 panel.The customer reported that the patient was not impacted due to the false negative p.Aeruginosa result.Quality control (qc) records for pouch lot# 34sz23 (kit lot# 6338023) and filmarray 2.0 instrument (serial number # (b)(6) were reviewed.The pouch lot and instrument passed qc criteria.The discrepancy reported by the customer was not observed during qc testing.In-house investigation: the filmarray 2.0 instrument (b)(6) was brought in for service.During service, it was identified that the false negative result observed at the customer site was likely due to poor fluid movement and array fill issues, which was caused by intermittent failures of a valve in the instrument.The intermittent failures of the valve were likely due to component wear out.Several other parts were identified to have damage and were replaced.Conclusion: the investigation concluded that the mostly likely cause for the discrepant p.Aeruginosa result was an instrument issue.The in-house investigation of filmarray 2.0 instrument (b)(6) found a valve was failing in the instrument likely due to component wear out.Intermittent failures of a valve in the instrument can lead to poor fluid movement and array fill issues leading to erroneous results.This may explain why p.Aeruginosa was detected in the repeat biofire bcid2 panel run provided by the customer, but not in the initial run.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.No false negative p.Aeruginosa results were observed during qc testing for pouch lot 34sz23 and there have not been any other field reports of false negative p.Aeruginosa results for the same pouch lot.The biofire bcid2 panel pouch lot is not suspected to have contributed to the observed discrepancy.A negative biofire bcid2 panel result does not exclude the possibility of bloodstream infection.Negative test results may occur from sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up, or an infection caused by an organism not detected by the panel.Test results may also be affected by concurrent antibacterial/antifungal therapy or levels of organism in the sample that are below the limit of detection for the biofire bcid2 panel (especially in the case of mixed cultures).Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions.The customer was shipped a replacement filmarray 2.0 instrument, and it was communicated that the new instrument is "already working at the customer site." clinical performance for the p.Aeruginosa assay can be found in table 36 in biofire bcid2 panel instruction for use (ifu) (www.Online-ifu.Com/iti0048).
Event or Problem Description
Summary: ospedale ca' foncello treviso (treviso, italy) reported a potential false negative pseudomonas aeruginosa result on the biofire blood culture identification (bcid2) panel after testing a patient sample.The patient was not impacted due to the biofire bcid2 panel result.The investigation concluded that the mostly likely cause for the discrepant p.Aeruginosa result was filmarray 2.0 instrument issue.

• Brand Name: FILMARRAY® 2.0 INSTRUMENT
• Common Device Name: FILMARRAY® 2.0 INSTRUMENT
• 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: 21380536
• Report Number: 3002773840-2025-00008
• Device Sequence Number: 12877213
• Product Code: NSU
• UDI-Device Identifier: 00815381020031
• UDI-Public: 00815381020031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: FLM2-ASY-0001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male