MAUDE Adverse Event Report: BioFire Diagnostics, LLC FILMARRAY GI PANEL

Model Number	RFIT-ASY-0116
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Summary: the customer (aviles, spain) reported a potential false positive giardia lamblia (g.Lamblia) result on the biofire® filmarray® gastrointestinal (gi) panel after testing a patient stool sample.The customer reported that due to the gi panel result, the patient was indirectly impacted, specifically by inappropriate treatment, which might lead to serious injury if it were to recur.No patient harm was reported.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.

• Brand Name: FILMARRAY GI PANEL
• Common Device Name: FILMARRAY GI 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 ; +1(385)770-1328
• MDR Report Key: 50714064
• Report Number: 3002773840-2026-00066
• Device Sequence Number: 10611576
• Product Code: PCH
• UDI-Device Identifier: 00815381020109
• UDI-Public: 00815381020109
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K242367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2026
• Device Model Number: RFIT-ASY-0116
• Device Lot Number: 1576225
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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: Other
• Patient Age: 4 YR
• Patient Sex: Female