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

Model Number	BIONOVA IC10/20FRLCD
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	07/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user informed that the auto-reader gave out false negative results.There was no report of infection, injury or harm to patients or procedure delay.
Additional Manufacturer Narrative
A user reported that incubator gave false negative readouts for positive control biological indicators, internal test reveals that there may have been dust in the indicator's position.No further information was provided.No device-related deaths or serious injuries were informed and there is no objective evidence of product malfunction.

• Brand Name: BIONOVA
• Common Device Name: AUTO-READER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional n[?]9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 19504688
• Report Number: 3013145340-2024-00024
• Device Sequence Number: 4019806
• Product Code: FRC
• UDI-Device Identifier: 07798164676706
• UDI-Public: 07798164676706
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• 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): 06/10/2021

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 Model Number: BIONOVA IC10/20FRLCD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown