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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Polydipsia (2604); Insufficient Information (4580); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a user of the ilet experienced hyperglycemia, noting high glucose readings on the pump and fingerstick values of 500 mg/dl followed by 599 mg/dl, with the agent guiding the user through a supply change.Symptoms included blurred vision, sleepiness, and thirst consistent with hyperglycemia.Outcomes included no hospitalization and completion of troubleshooting and user education.Investigation included customer interview and remote troubleshooting.Investigation of this case revealed no confirmed device malfunction, and the cause of the hyperglycemia remained unclear.It was concluded, based on previously established findings for similar reports, that the cause was indeterminate.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 ; 9492888350
• MDR Report Key: 24737935
• Report Number: 3019004087-2026-40080
• Device Sequence Number: 19723701
• Product Code: QFG
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female