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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ilet displayed a persistent ¿charge ilet now¿ message and failed to charge despite extended time on the charging pad, repositioning, use of alternate outlets, and removal of the case clip, resulting in battery depletion and interruption of insulin delivery; the patient¿s cgm showed a highest glucose of 327 mg/dl during approximately 10 hours without insulin, and the device was not connected to the infusion set during this period, consistent with a device battery problem involving the battery component.Symptoms included hyperglycemia.Outcomes included no health consequences or impact.Investigation included interviews and analysis of information provided by the user.Investigation of this case revealed an energy storage system problem consistent with premature battery discharge associated with the battery component.It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.The patient planned to contact a healthcare provider for backup therapy.

• 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: 50952059
• Report Number: 3019004087-2026-68471
• Device Sequence Number: 15840727
• 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
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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: 55 YR
• Patient Sex: Female