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

Model Number	BB1001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553)
Date of Event	09/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hypoglycemia with a lowest cgm reading of 60 following a period of hyperglycemia, felt lightheaded and confused/disoriented, and treated the low with two glasses of orange juice per healthcare provider guidance; the patient uses a g7 cgm and expressed confusion regarding pump use and differing instructions, and the cause of the event was unclear.Symptoms included hypoglycemia, confusion/disorientation, and dizziness.Outcomes included an unexpected medical intervention in the form of oral glucose and the event was characterized as a serious injury/illness/impairment.Investigation included communication/interviews and analysis of information provided by the user.Investigation of this case revealed no findings available, with insufficient information for a device problem or component determination.It was concluded, based on previously established findings for similar reports, that the cause was not established.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: 50942416
• Report Number: 3019004087-2026-68341
• Device Sequence Number: 13446737
• 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): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/12/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female