MAUDE Adverse Event Report: Beta Bionics, Inc. iLet Bionic Pancreas; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a supply change an alert 38 motor stall occurred and persisted after a restart, preventing supply changes or dry runs, consistent with a device failure to infuse associated with the motor component.Symptoms included no clinical signs, symptoms, or conditions.Outcomes included no health consequences or impact.Investigation included communication with the user and analysis of information provided by the user or third party.Investigation of this case revealed a communications problem identified in relation to a failure to infuse involving the motor component.It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.If the device is returned, a physical evaluation will be performed, and a supplemental will be submitted.

• 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 ; +1(949)288-8350
• MDR Report Key: 50941604
• Report Number: 3019004087-2026-68287
• Device Sequence Number: 10735126
• Product Code: QFG
• UDI-Device Identifier: 00850050080183
• UDI-Public: 00850050080183
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female