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

Model Number	BB1001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of a remedial submission made in response to fda form 483 observations to ensure full reporting compliance.
Event or Problem Description
It was reported that after an infusion site change, the user experienced hyperglycemia with blood glucose rising from 79 mg/dl to a peak of 345 mg/dl, remaining above 180 mg/dl for approximately two hours, with no device alerts above 300 mg/dl for over 90 minutes and no evidence of site leakage or blood; the device date was set incorrectly and corrected during the call, and charts indicated a period without insulin for over two hours followed by a meal.Symptoms included hyperglycemia without dizziness, loss of consciousness, or diabetic ketoacidosis.Outcomes included no use of backup therapy, no ketone testing, no assistance required, and no medical intervention or hospitalization.Investigation included review of uploaded device reports and user guidance on correcting device date settings, along with education on monitoring and reassessment.Investigation of this case revealed hyperglycemia with cause unclear, with contributing factors possibly including the incorrect device date setting, a period without insulin delivery, and timing of meal intake; no device alarms were triggered and no infusion site issues were detected.It was concluded, based on previously established findings for similar reports, that the cause was undetermined.

• 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: 24185795
• Report Number: 3019004087-2026-24577
• Device Sequence Number: 15456285
• Product Code: QFG
• UDI-Device Identifier: 00850050080237
• UDI-Public: 00850050080237
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: BB1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown