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	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced multiple occlusion alerts with inset 23" infusion sets connected to an ilet, occurring predominantly 1¿6 hours after site changes, often during the night and after meal announcements, with only 20¿40% of meal insulin delivered and proper priming steps and connections confirmed.Symptoms included hyperglycemia with continuous glucose monitor (cgm) high and blood glucose of 400 mg/dl, accompanied by thirst.Outcomes included interruption of insulin delivery requiring repeated supply and site changes, and continued alerts until replacement supplies from a different lot were used.Investigation included remote troubleshooting, a pump dry run confirming adequate pump motor performance, and user education on full supply changes and monitoring.Investigation of this case revealed no visible kinks, clogs, or blood in the cannula or tubing, drops seen during initial fill, correct connections, potential contribution from scar tissue at the upper buttocks site and pump worn below the site, and a lot-specific pattern reported by the user, indicating infusion set occlusion related to the infusion set and/or site rather than the pump.It was concluded, based on previously established findings for similar reports, that the cause was infusion set/site-related occlusion potentially exacerbated by tissue condition and resolved by changing to new supplies.
Event or Problem Description
It was reported that the patient experienced multiple occlusion alerts with inset 23" infusion sets connected to an ilet, occurring predominantly 1¿6 hours after site changes, often during the night and after meal announcements, with only 20¿40% of meal insulin delivered and proper priming steps and connections confirmed.Symptoms included hyperglycemia with continuous glucose monitor (cgm) high and blood glucose of 400 mg/dl, accompanied by thirst.Outcomes included interruption of insulin delivery requiring repeated supply and site changes, and continued alerts until replacement supplies from a different lot were used.Investigation included remote troubleshooting, a pump dry run confirming adequate pump motor performance, and user education on full supply changes and monitoring.Investigation of this case revealed no visible kinks, clogs, or blood in the cannula or tubing, drops seen during initial fill, correct connections, potential contribution from scar tissue at the upper buttocks site and pump worn below the site, and a lot-specific pattern reported by the user, indicating infusion set occlusion related to the infusion set and/or site rather than the pump.It was concluded, based on previously established findings for similar reports, that the cause was infusion set/site-related occlusion potentially exacerbated by tissue condition and resolved by changing to new supplies.

• 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: 50934732
• Report Number: 3019004087-2026-68145
• Device Sequence Number: 18564211
• 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,Followup
• 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: 09/17/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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; Convatec Infusion Set - Inset
• Patient Age: 17 YR
• Patient Sex: Male