MAUDE Adverse Event Report: BETA BIONICS INC. ILET BIONIC PANCREAS; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user¿s ilet charging pad appeared not to work until the agent guided the user to try a different power outlet, after which the battery showed charging and the pad¿s green indicator illuminated.Symptoms included no clinical symptoms.Outcomes included no impact to health and no alarms.Investigation included remote troubleshooting and user education.Investigation of this case revealed normal device function after outlet change, consistent with a power source issue rather than a charger or pump malfunction.It was concluded that the cause was user environment or setup related.

• Brand Name: ILET BIONIC PANCREAS
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): BETA BIONICS INC.; 11 hughes; irvine CA 92618
• Manufacturer (Section G): BETA BIONICS, INC.; 11 hughes; irvine CA 92618
• Manufacturer Contact: jared fukushima ; 11 hughes; irvine, CA 92618 ; 9492888350
• MDR Report Key: 24063643
• Report Number: 3019004087-2026-21654
• Device Sequence Number: 9113299
• Product Code: QFG
• UDI-Device Identifier: 00850050080237
• UDI-Public: 00850050080237
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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?: No
• Operator of Device: Lay User/Patient
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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: A
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown