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

Model Number	BB1001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
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 a patient experienced a blood glucose reading of 204 mg/dl after the ilet pump lost power due to a depleted battery, which stopped insulin delivery until the pump was recharged and restarted.Symptoms included no reported clinical symptoms.Outcomes included no medical intervention or hospitalization.Investigation included troubleshooting and education regarding power management and confirmation that insulin delivery resumes when the device is powered and reconnected.The ilet bionic pancreas system user guide (ifu) was reviewed as part of the investigation.Section 4.3.1 of the ifu was found to include instructions and/or warnings relevant to the reported event.No deficiencies in the ifu that would have contributed to the complaint were identified.Investigation of this case revealed user-related interruption of therapy because the patient did not use alternative insulin therapy after the pump shut off, with contributing factors of low and very low battery.It was concluded, based on previously established findings for similar reports, that the cause was user-related therapy interruption due to inadequate charging practices.

• 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: 50938684
• Report Number: 3019004087-2026-68215
• Device Sequence Number: 9598150
• Product Code: QFG
• UDI-Device Identifier: 00850050080206
• UDI-Public: 00850050080206
• 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): 09/29/2026

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
• Was Device Available for Evaluation?: No
• 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: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Convatec Inset; Dexcom G7 CGM
• Patient Age: 82 YR
• Patient Sex: Female