MAUDE Adverse Event Report: Beta Bionics, Inc. iLet Bionic Pancreas; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	BB1001
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ilet insulin pump experienced rapid battery depletion after charging to full, with the battery dropping by roughly one-third during a meal announcement and repeating over multiple days, consistent with a premature battery discharge involving the battery component.Symptoms included hyperglycemia with a highest reported blood glucose of 400 mg/dl.Outcomes included a missed dose and a delay to therapy.Investigation included interviews and analysis of information provided by the user and engineering logs.Investigation of this case revealed an energy storage system problem consistent with premature discharge of the battery component.It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.

• 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 ; +1(949)288-8350
• MDR Report Key: 50952207
• Report Number: 3019004087-2026-68481
• Device Sequence Number: 10451407
• Product Code: QFG
• UDI-Device Identifier: 00850050080190
• UDI-Public: 00850050080190
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BB1001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male