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	05/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On may 7, 2020, customer called technical support (ts) and reported hearing a loud noise during a test run on a revogene instrument and then smelled a burning odor.Customer stated that she immediately turned off the revogene instrument.Ts instructed customer to turn the revogene instrument back on in order to open the lid to see if a pie was dislodged, as this could potentially cause the series of events that were being reported.Customer stated that she was performing one patient test and the rest were mock pies.Ts asked customer if mock pies are removed after each test run and customer stated that, yes, they were.Once the lid was opened, customer stated that the pie containing the patient sample appeared to be slightly raised.Ts advised customer to check that all pies are secure, even after putting retention ring in place.Ts also advised customer to ensure that the sensors on the lid do not appear to have material coating them as a result of the dislodged pie, and if so, to wipe them off with alcohol.Ts advised customer that she will need to repeat the patient test from the beginning as the pie can not be reused.Customer to repeat testing.Customer reported that repeat testing worked as expected and there have been no further issues.Customer is satisfied with ts assistance and follow-up.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: 22331257
• Report Number: 1524213-2025-00002
• Device Sequence Number: 8410608
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: 00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 05/07/2020
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2017
• 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