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); Loss of consciousness (2418)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 the reporter reported that on (b)(6) 2026 the user experienced hypoglycemia with blood glucose (bg) levels unknown.The user was transported to the hospital by paramedics where the user was treated with fluids and discharged (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 date of (b)(6) 2026.No 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 dosing was adjusted in response to cgm glucose values.A dexcom g7 sensor was in use during the reported event.Brief sensor issues were observed; however, the available information does not establish that these sensor issues contributed to the reported hypoglycemic event.The user experienced hypoglycemia with loss of consciousness and was transported to the hospital by paramedics.The user was treated with fluids and discharged after blood glucose stabilized.The user and caregiver were unable to provide the blood glucose value associated with the event.The user subsequently resumed ilet therapy.The investigation did not identify an ilet device malfunction associated with the reported event.

• 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: 50515056
• Report Number: 3019004087-2026-62595
• Device Sequence Number: 21159545
• 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: 03/25/2026
• 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: 63 YR
• Patient Sex: Male