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

Model Number	BB1001
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced persistent hyperglycemia while using ilet with fl3 cgm and an inset infusion set on the abdomen, including a cgm value near 400 mg/dl and subsequent fingerstick values up to 564 mg/dl, with an occlusion alert initially and a bent cannula (reported on a separate case) observed upon site removal that resolved after a full supply change; later, another supply change was performed, and glucose eventually trended to 180 mg/dl.No adverse clinical symptoms associated with hyperglycemia reported.Outcomes included no health consequences or impact.Investigation included communication with the patient and analysis of information provided by the user.Investigation of this case revealed no device problem found, with lack of effect due to insulin delivery interruption consistent with an infusion set issue and insufficient information regarding a specific device component.It was concluded, based on previously established findings for similar reports, that the cause was not established.

• 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: 50935876
• Report Number: 3019004087-2026-68172
• Device Sequence Number: 9589351
• 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
• 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?: 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Convatec Infusion Set - Inset
• Patient Age: 78 YR
• Patient Sex: Female