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

Model Number	BB2001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Hyperglycemia (1905); Muscle Weakness/Atrophy (1967); Elevated ketones/Diabetic Ketoacidosis (2364); Polydipsia (2604)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ilet pump¿s cartridge chamber was leaking during setup, prompting the user to switch to subcutaneous insulin via pens and experience hyperglycemia up to 400 mg/dl, with the issue associated to a leak/splash in the reservoir component.Symptoms included elevated ketones, headache, thirst, fatigue, and muscle weakness consistent with hyperglycemia.Outcomes included missed insulin doses, an unexpected need for medication, a delay to therapy, and characterization as a serious illness.Investigation included communication with the user, analysis of information provided by the user, a dry run on the pump, and guidance to perform a full supply change using new supplies.Investigation of this case revealed leakage at or related to a seal, consistent with a medical device leak/splash involving the reservoir component.It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.

• 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: 50946561
• Report Number: 3019004087-2026-68351
• Device Sequence Number: 10348707
• 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
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BB2001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male