MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. REVOGENE

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer was completing a test run utilizing 3 prepared revogene group a strep test devices and 5 revogene mockpies.The customer reported that the instrument aborted the test run after smoke appeared from the instrument.The lid was difficult to open and the retention ring was very warm.The pies showed signs of melting.There were no injuries or laboratory damage reported.While there was no injuries or deterioration of health reported with this incident, this incident has the potential to cause a burn through accidental contact with the heated instrument components or melted pies.Impact of burns could range from minor severity to serious injury depending on the location and duration of contact.The inability to complete the test run could lead to an inability to prescribe necessary treatment.Symptoms could progress and the disease state may worsen.

• Brand Name: REVOGENE
• Common Device Name: REVOGENE
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• MDR Report Key: 12374693
• Report Number: 1524213-2021-00001
• Device Sequence Number: 5003165
• Product Code: OOI
• UDI-Device Identifier: 00840733102318
• UDI-Public: (01)00840733102318
• Combination Product (Y/N): N
• 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,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 03/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 610210
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1