MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® PNEUMONIA PANEL PLUS

Model Number	RFIT-ASY-0143
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation: the patient was a 65-year-old male.The customer reported that the patient was admitted to the hospital on (b)(6) 2025, with dyspnea and hemoptysis.At the time of testing, the patient was intubated and ventilated in the icu and on tazobactam.On (b)(6) 2025, a patient's bal sample was tested on filmarray pneumonia panel plus.The filmarray pneumonia panel plus reported all analytes as not detected.On (b)(6) 2025, the patient's sample was retested on the filmarray pneumonia panel plus.The filmarray pneumonia panel plus reported k.Oxytoca, k.Pneumoniae group, and ctx-m as detected.The customer reported chest computed tomography (ct) scan was suggestive of cytomegalovirus infection, clinical worsening and worsening of lesions.On an unknown date, meropenem for k.Pneumoniae esbl was introduced.The customer stated that the patient rapidly improved on (b)(6) 2025, with extubation.The patient died on (b)(6) 2025.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the final report.Conclusion: investigation ongoing.
Event or Problem Description
Summary: (b)(6) france, reported a potential false negative klebsiella oxytoca, klebsiella pneumoniae group, and ctx-m result on the filmarray pneumonia panel plus after testing a patient's bronchoalveolar lavage (bal) sample.It is unknown if there was any impact to the patient due to the filmarray pneumonia panel plus result.Biofire has requested further information from the customer and is currently investigating this event.
Additional Manufacturer Narrative
Investigation: the patient was a 65-year-old male.The customer reported that the patient was admitted to the hospital on (b)(6) 2025, with dyspnea and hemoptysis.At the time of testing, the patient was intubated and ventilated in the intensive care unit (icu) and on tazobactam.On (b)(6) 2025, a patient's bal sample was tested on filmarray pneumonia panel plus.No results were obtained due to a control failure.The filmarray pneumonia panel plus was repeated 2 hours later.The filmarray pneumonia panel plus reported all analytes as not detected.On (b)(6) 2025, the patient's sample was retested on the filmarray pneumonia panel plus.The filmarray pneumonia panel plus reported k.Oxytoca, k.Pneumoniae group, and ctx-m as detected.The customer reported that the negative filmarray pneumonia panel plus results were communicated to the physician in the evening of (b)(6) 2025, and the modified result was provided in the early afternoon of (b)(6) 2025.The same sample was used for additional testing.An unknown pcr test was positive for epstein-barr virus and cytomegalovirus (cmv).The customer reported that quantitative culture identified 3×10² k.Pneumoniae esbl and 10² stenotrophomonas maltophilia.Note, the filmarray pneumonia panel plus does not detect s.Maltophilia.The patient's blood sample was also tested using an unknown pcr test and was positive for cmv.When asked if the patient was affected by the filmarray pneumonia panel plus result, the customer communicated the following: the patient was admitted to the hospital on (b)(6) 2025, with dyspnea and hemoptysis, chest computed tomography (ct) scan was suggestive of cytomegalovirus infection, clinical worsening and worsening of lesions on ct scan, meropenem for k.Pneumoniae esbl was introduced, rapid improvement was seen on (b)(6) 2025, with extubation, and the patient died on (b)(6) 2025.It is unknown if the patient was impacted by the filmarray pneumoniae panel plus result.Biofire requested clarification from the customer on whether the patient was affected by the filmarray pneumoniae panel plus result, but despite multiple attempts, no further information was provided.Conclusion: based on the information provided, the investigation found the most likely cause of the control failure and false negative k.Oxytoca, k.Pneumoniae, and ctx-m results was a reagent manufacturing error.Preliminary investigation into kit lot # 0979424/ pouch lot # 3blf24 of the filmarray pneumonia panel plus identified increased risk of control failures and false negative test results on this specific pouch lot.This was communicated to customers via field safety corrective action (fsca) fa-twd-000033, which was issued to subsidiaries and distributors on february 28, 2025.Biofire is currently investigating the issue and taking appropriate corrective and preventive actions.Biofire recommends that the customer follow the instructions in fsca fa-twd-000033, including stopping use and discarding product from kit lot # 0979424/ pouch lot # 3blf24.Clinical performances can be found in tables 22, 24, 56, and 59 of the filmarray pneumonia panel plus ifu (www.Online-ifu.Com/iti0038).
Event or Problem Description
Summary: (b)(6) hôpital (france) reported a control failure and a potential false negative klebsiella oxytoca, klebsiella pneumoniae group, and ctx-m result on the filmarray pneumonia panel plus after testing a patient's bronchoalveolar lavage (bal) sample.It is unknown if the patient was impacted due to the filmarray pneumonia panel plus result.Based on the information provided, the investigation found that the most likely cause of the control failure and the false negative k.Oxytoca, k.Pneumoniae, and ctx-m results was a reagent manufacturing error.

• Brand Name: FILMARRAY® PNEUMONIA PANEL PLUS
• Common Device Name: FILMARRAY® PNEUMONIA PANEL PLUS
• 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 ; 3857701328
• MDR Report Key: 21715470
• Report Number: 3002773840-2025-00018
• Device Sequence Number: 10010419
• Product Code: QDS
• UDI-Device Identifier: 00815381020314
• UDI-Public: 00815381020314
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222601
• 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,Followup
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2025
• Device Model Number: RFIT-ASY-0143
• Device Lot Number: 0979424
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Male