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

Model Number	BB1001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ilet displayed alert 57 and the user restarted the ilet; the user also had backup therapy available and was using a dexcom g7 sensor, which aligns with a computer software problem related to the device¿s computer software component.Symptoms included no clinical signs, symptoms, or conditions.Outcomes included no health consequences or impact.Investigation included communication with the user, analysis of information provided by the user or third party, and an event history log review.Investigation of this case revealed a software runtime error consistent with a computer software problem in the computer software component.It was concluded, based on previously established findings for similar reports, that the cause was traced to software coding.If the device is returned, a physical evaluation will be performed, and a supplemental will be submitted.

• 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: 50922700
• Report Number: 3019004087-2026-67949
• Device Sequence Number: 17491185
• 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
• Remedial Action: Notification,Recall,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 09/05/2026
• Initial Report FDA Received Date: 09/28/2026
• 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
• Patient Age: 28 YR
• Patient Sex: Male