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); Vomiting (2144); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 the user reported that on (b)(6) 2026 the user experienced hypoglycemia with blood glucose (bg) levels of 41 mg/dl following treatment of the initial low glucose alert with food and a beverage.The user was transported to the hospital by a caregiver where the user was treated with iv glucose and discharged on (b)(6) 2026.No long-term health effects were reported.
Additional Manufacturer Narrative
The complaint investigation was performed by evaluation of the device engineering logs for the reported event on (b)(6) 2026.No instances of malfunction alerts or factory resets were identified.No motor errors were identified to indicate inaccurate insulin dosing relative to delivery requests.Review of the available data determined that the ilet was behaving as intended, alerts were triggered appropriately, and insulin doses were adjusted in response to cgm glucose values.The reported hypoglycemic event included a bg level of 41 mg/dl, loss of consciousness, seizure, and vomiting.The user was transported to the hospital by a caregiver, treated with iv glucose, and released without hospital admission.No outside insulin, meal announcements, or supply changes were reported prior to the event.The investigation did not identify an ilet device malfunction associated with the reported event.The device engineering log review determined that the ilet functioned as intended during the reviewed period.

• 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: 50515060
• Report Number: 3019004087-2026-62596
• Device Sequence Number: 13088784
• Product Code: QFG
• 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): 08/30/2026

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: 08/12/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Dexcom G7 CGM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Unknown