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	Hypoglycemia (1912); Muscle Weakness/Atrophy (1967)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user was awakened by a low glucose alert with a pump reading of 55 mg/dl during sleep, with no identified precipitating factor, and glucose subsequently rose without carbohydrate intake.Symptoms included slight weakness consistent with hypoglycemia.Outcomes included self-resolution with current blood glucose of 101 mg/dl and no need for medical intervention or hospitalization.Investigation included troubleshooting and education with instructions to continue monitoring and to call back if further issues arose.Investigation of this case revealed no device malfunction reported, no pump or component damage identified, and no user-reported errors, and the event was characterized as hypoglycemia with unclear cause during sleep.It was concluded, based on previously established findings for similar reports, that the cause was undetermined.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: 24738179
• Report Number: 3019004087-2026-40092
• Device Sequence Number: 19718690
• 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: 03/09/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female