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	09/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On september 14, 2020, customer called technical support (ts) and reported during a run on a revogene instrument they smelled a burning odor.Customer stated that they immediately aborted the run on the revogene instrument.Ts informed them that a burning smell is typically a pie rubbing against the inside of the revogene instrument because it isn't seated properly.Revogene instrument was on a cabinet which may not be stable enough for the revogene instrument.The revogene instrument was moved to a counter and another instrument moved to the cabinet.Customer is satisfied with ts assistance.It is a known failure mode that improperly setting pies in the rotor can lead to a "blocked rotor" and left unattended can result in the smell of heated plastic; however, the instrument will shut down if the rotor becomes blocked.The product labeling describes the importance of seating pies in the rotor properly.This complaint was found as part of a review for mdr 1524213-2024-00001 and after careful review, meridian has elected to report out of an extreme abundance of caution.There were no reported claims of serious injury or harm as a result of the burning smell.

• 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: 22331330
• Report Number: 1524213-2025-00003
• Device Sequence Number: 9582717
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: 00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown