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

Model Number	BB1001
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
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 the user experienced sustained hyperglycemia while using the ilet system and changed the teflon 6 mm, 23-inch infusion set multiple times, with device alerts for prolonged high glucose; the cause was unclear and troubleshooting and education were provided.Symptoms included elevated blood glucose without reported acute clinical effects.Outcomes included no medical intervention, no hospitalization, no assistance from others, and no ketone testing or backup therapy.Investigation included user interview and troubleshooting focused on infusion set function and potential occlusion or kinking.Investigation of this case revealed no confirmed device malfunction, and user education emphasized checking for infusion set kinking and proper set function to address potential infusion delivery issues.It was concluded, based on previously established findings for similar reports, that the cause was inconclusive.

• 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: 24094989
• Report Number: 3019004087-2026-22357
• Device Sequence Number: 9201573
• Product Code: QFG
• UDI-Device Identifier: 00850050080183
• UDI-Public: 00850050080183
• 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): 01/16/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/16/2026
• 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: 58 YR
• Patient Sex: Unknown