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

Model Number	BB1001
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ilet displayed an alert to connect the cgm or enter a bg with dosing set to stop in several hours after the user started a new dexcom g7 sensor, and no cgm readings appeared on the ilet or phone until the user unlocked the ilet following troubleshooting that included restarting the ilet, toggling between g6 and g7 sensor types, and re-pairing with the g7 using pairing code 8653; the problem aligns with intermittent communication failure involving the electrical and magnetic subsystem, specifically the antenna, in the context of dexcom g7 interoperability.Symptoms included no clinical signs, symptoms, or conditions.Outcomes included no health consequences or impact.Investigation included communication with the user and analysis of information provided by the user.Investigation of this case revealed an interoperability problem identified between the ilet and the dexcom g7 manifesting as intermittent communication failure attributable to the antenna 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: 50950647
• Report Number: 3019004087-2026-68424
• Device Sequence Number: 10451739
• 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
• 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: 09/06/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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: Dexcom - G7
• Patient Age: 61 YR
• Patient Sex: Male