MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. REVOGENE

Model Number	610210
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meridian bioscience canada, the instrument's contract manufacturer, completed a review of the instrument's raw data and system event reports.During this review, it was identified that the instrument aborted runs on (b)(6) 2022, (b)(6) 2022, and (b)(6) 2022, after error code "057-003" was presented.An additional aborted run occurred on (b)(6) 2022, after error code "058-003" was presented.These error codes ("057-003" and "058-003") are presented when the excitation result value is under a defined threshold for a specific channel.These error codes are indicative of a malfunctioning photomultiplier tube.When error codes 057 and 058 occurs, the revogene is at the end of the annealing step (no matter which cycle it happens).At that moment, the instrument is around 55-60°c.
Event or Problem Description
The customer reported that the instrument began aborting runs.Upon the first aborted patient run (on (b)(6) 2022), the customer noted that the instrument was "super-hot" inside of the lid.The customer then experienced an aborted patient run on (b)(6) 2022 and the noted the instrument was "unusually warm" on the inside of the lid.The instrument also aborted a patient run on (b)(6) 2022.Meridian became aware of this event on (b)(6) 2022.While no claims of injury or burns were reported with each occurrence, meridian has elected to submit this report out of an abundance of caution.

• Brand Name: REVOGENE
• Common Device Name: REVOGENE
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: megan berling ; 3471 river hills dr.; cincinnati, OH 45244 ; 5139914142
• MDR Report Key: 15258669
• Report Number: 1524213-2022-00007
• Device Sequence Number: 5745475
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: (01)00840733102318
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 04/06/2023
• Device Model Number: 610210
• Device Catalogue Number: 610210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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