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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user experienced repeated occlusion alerts while using the infusion set and associated disposables, with alerts recurring despite multiple full supply changes and no observed bent cannulas, kinked tubing, or air bubbles; at one point the user disconnected and administered manual injections, then later resumed pump delivery after priming the tubing per troubleshooting.Symptoms included an interruption of insulin delivery consistent with an occlusion event without medical intervention.Outcomes included temporary reliance on manual injections with subsequent restoration of pump delivery after troubleshooting and supply changes, without hospitalization reported.Investigation included guided troubleshooting and education, including disconnection, tubing fill, and resumption of insulin delivery.Investigation of this case revealed an occlusion consistent with flow restriction in the disposable pathway, unresolved until supply change and line priming, with no confirmed hardware malfunction noted.It was concluded, based on previously established findings for similar reports, that the cause was user technique and disposable-related flow obstruction.

• 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: 50945935
• Report Number: 3019004087-2026-68344
• Device Sequence Number: 18516418
• Product Code: QFG
• UDI-Device Identifier: 00850050080190
• UDI-Public: 00850050080190
• 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?: 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: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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: 75 YR
• Patient Sex: Male