MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. REVOGENE

Catalog Number	610210
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, meridian bioscience inc.Technical service department received a call from a customer who reported a full run of indeterminate results obtained during testing with the revogene group a strep assay.Customer also reported a burning smell during the run.When the run was completed, the customer observed that the microfluidic pies were melted.Customer had their clinical engineering department check the outlet and the circuit the revogene was plugged into and everything checked out ok.Customer did not observe any visible damage to the instrument other than the melted pies.While there were no reported claims of serious injury or harm were reported, meridian has elected to submit this report out of an extreme abundance of caution.
Additional Manufacturer Narrative
A preliminary investigation was completed by the instrument's contract manufacturer, meridian bioscience canada.This investigation confirmed that the instrument's cooling period was functioning properly thus reducing any risks associated with incidental contact with heated components by the user.

• Brand Name: REVOGENE
• Common Device Name: REVOGENE
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer (Section G): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: megan berling ; 3471 river hills dr.; cincinnati, OH 45244
• MDR Report Key: 23480262
• Report Number: 1524213-2025-00004
• Device Sequence Number: 16003154
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: 00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K243922
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 Catalogue Number: 610210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown