MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. REVOGENE

Model Number	610210
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, a meridian technical service representative was at the customer site assisting with instrument installation.During installation, a self-test was initiated.Continued on page 3.
Additional Manufacturer Narrative
This is a follow up report made at the request of the agency.The initial report for mdr# 1524213-2021-00002 was submitted by meridian bioscience inc.On october 14, 2021.An investigation into the root cause of this event was completed.The root cause of this event is attributed to a defective pcr heating module, specifically the end of the internal coiled wire was turned inside-out.As a corrective action, additional verifications of the part and of the different assembly steps are to be implemented.H11: additional details on event description: after initiation of the self-test, the instrument became very hot and there was a burnt plastic smell coming from the instrument.The instrument was immediately turned off.The following day, an additional self-test was initiated.About one minute into this self-test smoke began to come out of the bottom of the instrument.Upon removal of the mock pies, it was noted that the instrument was extremely hot to the touch.There was no visible damage to the mock pie or instrument.This event occurred during instrument installation at a customer site.There were no false, discrepant, or questionable results reported by the customer.

• Brand Name: REVOGENE
• Common Device Name: REVOGENE
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: 3471 river hills dr; cincinnati, OH 45244
• MDR Report Key: 12632718
• Report Number: 1524213-2021-00002
• Device Sequence Number: 14513021
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: (01)00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Expiration Date: 06/10/2022
• Device Model Number: 610210
• Device Catalogue Number: 610210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown