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 Code	Hypoglycemia (1912)
Date of Event	09/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user experienced hypoglycemia while the ilet pump was paused, with cgm readings as low as 50 mg/dl and a concurrent fingerstick of 76 mg/dl, and remote review confirmed a recorded pause, no insulin delivery during the low event aside from a small dose earlier, and a data gap likely related to charging; the agent advised rechecking every 15 minutes and explained that insulin suspension occurs at the target threshold and that individual physiology can allow continued bg decline despite suspension.Symptoms included hypoglycemia without reported physical symptoms.Outcomes included self-treatment with four glucose tablets and a snack and continued home monitoring without hospitalization.Investigation included remote data review through the app and verification of pump pause status and delivery history, along with offer to escalate for internal software review.Investigation of this case revealed no evidence of insulin delivery during the event and no device alarms, consistent with expected suspend behavior, with the low glucose attributed to physiological factors rather than device malfunction.It was concluded, based on previously established findings for similar reports, that the cause was unclear.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: 50946519
• Report Number: 3019004087-2026-68350
• Device Sequence Number: 10451998
• 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?: 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: 08/27/2024
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male