MAUDE Adverse Event Report: TERRAGENE S.A. BIOTRACE; AUTO-READER INCUBATOR

Model Number	BIOTRACE AUTO READ PRO BIOLOGICAL INDICATOR READER
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related deaths or serious injuries were informed.The historical record of the device was checked and no deviations were found.Terragene requested the auto-reader to the final user for a thorough inspection to determine the cause of malfunction.A follow-up will be made after terragene receives the device.
Event or Problem Description
The customer reports that their reader could not reach the temperature selected.Additionally, the auto-reader gave out false positive and false negative results.The customer also notes that the temperature unit is being misrepresented, showing celsius instead of fahrenheit and vice versa.There was no report of infection, injury or harm to patients or procedure delay.

• Brand Name: BIOTRACE
• Common Device Name: AUTO-READER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 22119854
• Report Number: 3013145340-2025-00001
• Device Sequence Number: 19896415
• Product Code: FRC
• UDI-Device Identifier: 07798375772471
• UDI-Public: (01)07798375772471(10)734002424
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K191021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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 Model Number: BIOTRACE AUTO READ PRO BIOLOGICAL INDICATOR READER
• Device Catalogue Number: 73400
• Device Lot Number: 2424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown