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 Code	Hyperglycemia (1905)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an ilet user experienced hyperglycemia after announcing a meal, with no pump alarms, no reported infusion set leaks, and continued high readings; the user did not confirm with a fingerstick and planned either a set change or a manual injection with temporary pump disconnection as advised.Symptoms included elevated blood glucose up to 380 mg/dl without reported ketones, medical intervention, or acute complications.Outcomes included no hospitalization, no need for assistance, and no long-term health impact reported.Investigation included complaint intake, user education on troubleshooting steps, and assessment of pump alerts and infusion set status.Investigation of this case revealed no device alarms or confirmed delivery interruption and no confirmed component failure, so the cause of the hyperglycemia remained unclear.It was concluded, based on previously established findings for similar reports, that the cause was indeterminate.
Additional Manufacturer Narrative
This mdr is part of a remedial submission made in response to fda form 483 observations to ensure full reporting compliance.

• 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: 23930310
• Report Number: 3019004087-2025-18126
• Device Sequence Number: 18465529
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Unknown