MAUDE Adverse Event Report: BIOMÉRIEUX, INC / BIOFIRE DIAGNOSTICS, LLC BIOFIRE® FILMARRAY® GI PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number RFIT-ASY-0104

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Performance: on (b)(6) 2022, minnesota department of health shared the attached biomérieux technical bulletin regarding the biofire filmarray gastrointestinal (gi) panel with (b)(6) on (b)(6) 2022 nys released a statement that confirmatory testing for cryptosporidium was observed to have a significant drop in their reproducibility of results.On (b)(6) 2022 (b)(6) was updated by (b)(6), vice president, global marketing biofire, that ".Biomérieux has received an increased number of reports of unconfirmed cryptosporidium results (i.E."false positive" results) from customers using the biofire® filmarray® gastrointestinal (gi) panel." specifically, ".A subset of the unconfirmed cryptosporidium results appear to be caused by a previously unknown non-specific product that is being generated by the crypt 2 assay.This amplification product is being erroneously interpreted as "positive" by the software.".The company provided interim guidance on how to report cryptosporidium detections from the panel in (b)(6) 2022.The guidance was that ".If cryptosporidium is reported as detected and the crypt 1 assay is positive, or if both crypt 1 and crypt 2 assays are positive, then no action is needed.If the organism is reported as detected and only the crypt 2 assay is positive, then it is possible that this result is a false positive and therefore it should be confirmed by another method.".Quality: (b)(6) immediately suspended the auto-resulting function for cryptosproidium on gi panel testing and reflexed 'crypt2 peak only' samples (per biofire's guidance) to our local health department, mdh (minnesota department of health).Out of the 27 'crypt2 peak only' samples we have sent to mdh for confirmation, all of them have come back as "cryptosporidium oocysts negative by dfa".At this time, the laboratory still has additional samples that have confirmatory results pending.The instrument software was utilized to view historical 'crypt2' peaks only, and it was discovered that the percent positivity was 5.24% for the year so far in 2022.The performance of this panel is not meeting expectations we are used to experiencing with the biofire® filmarray® gastrointestinal (gi) panel.This issue has caused additional precautionary testing in order to ensure the quality of the laboratory results provided to the patients at (b)(6).In partnership with the minnesota department of health, both facilities have performed additional work, at the request of biomérieux, which requires resources such as, technologist time, additional hazardous shipping, management collaboration, and software/lis adjustments.The laboratory began sending samples to mdh for confirmation and completed samples at the time of this write up were over 50 samples that showed negative for cryptosporidium oocysts by dfa that had to have results revised.Safety concerns: cryptosporidium detections of 'crypt2 peak only' appear to be possible false-positive results which can result in appropriate diagnoses and management, including treatment, as well as failure to identify the real cause of a patient's gastroenteritis.It is unclear how far back in time this situation extends but it may have been ongoing for some time.According to biomérieux, this is a software problem.It is concerning that biomérieux has not issued a software fix after knowing about this problem for half a year.The (b)(6) bacteriology laboratory stores all of the kits and their components (reagents and buffers) at room temperature (15¿25 ºc), and only use the components provided in the kit from the manufacturer.Only stool specimens in cary blair media are used within the manufacturer¿s guidance.All products received are inspected and quality control is performed, by the quality area with each lot and shipment.Reference report: mw5117284.

• Brand Name: BIOFIRE® FILMARRAY® GI PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): BIOMÉRIEUX, INC / BIOFIRE DIAGNOSTICS, LLC; lake city UT 84108
• MDR Report Key: 16886405
• MDR Text Key: 314869256
• Report Number: MW5117283
• Device Sequence Number: 1
• Product Code: PCH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/03/2023

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 Catalogue Number: RFIT-ASY-0104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Patient Sequence Number: 1