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 Code	Hyperglycemia (1905)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user experienced hyperglycemia while using the ilet, with a reported blood glucose of 618 mg/dl on arrival to the emergency department and 374 mg/dl at discharge after receiving water, saline, and bloodwork.Symptoms included hyperglycemia.Outcomes included emergency department treatment and discharge.Investigation included case review.Investigation of this case revealed an event of hyperglycemia with cause unclear; no device malfunction or component failure was identified based on available information.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: 24738208
• Report Number: 3019004087-2026-40095
• Device Sequence Number: 9840325
• 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: 11/04/2025
• 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: 51 YR
• Patient Sex: Female