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

Model Number	STRYKER SLCD13
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	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related deaths or serious injuries were informed.Device malfunction cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness, since it would not be able to process biological indicators.If this were to recur, the lack of biological indicators processing could affect the load release, which could contribute to a serious injury due to lack of sterile material.
Event or Problem Description
According to the distributor representative, the autoreader incubator would not get to the working temperature, which would not let the autoreader start any biological indicator incubation.

• Brand Name: STRYKER
• 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: 18434242
• Report Number: 3013145340-2024-00004
• Device Sequence Number: 7567593
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: STRYKER SLCD13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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