MAUDE Adverse Event Report: TERRAGENE S.A TUTTNAUER WTL198-0057; AUTO-READER INCUBATOR

Model Number	TUTTNAUER WTL198-0057
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	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related deaths or serious injuries were informed and there is no evidence of product malfunction.As no further information was provided, we consider the negative readout for positive controls may have been caused by product misuse or a bi or auto-reader malfunction.Product malfunction may cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness which could contribute to death or serious injury if it were to recur.
Event or Problem Description
The user reported that positive control bis were showing negative results for the fluorescence readout.No further information was shared by the user or the distributor.

• Brand Name: TUTTNAUER WTL198-0057
• 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: 18475643
• Report Number: 3013145340-2024-00009
• Device Sequence Number: 6794334
• Product Code: JOJ
• UDI-Device Identifier: 07798164677475
• UDI-Public: 07798164677475
• Combination Product (Y/N): N
• 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): 01/09/2024

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
• Device Model Number: TUTTNAUER WTL198-0057
• Device Lot Number: WTL19800575321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown