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

Model Number	BB1001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418); Irritability (2421); Confusion/ Disorientation (2553); Lethargy (2560); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a low blood glucose event while sleeping, with a lowest value of 50 mg/dl, and was using the ilet pump; the patient received rapid-acting carbohydrates by mouth administered by another person after an urgent low alert and a rapid drop following prior pump-driven corrections and a subsequent pump pause and resume.Symptoms included hypoglycemia, loss of consciousness, sleepiness, confusion, irritability, lethargy, and vomiting.Outcomes included unexpected medication intervention and a serious injury or illness.Investigation included communication and interviews with the patient and analysis of information provided by the user or third party.The ilet bionic pancreas system user guide (ifu) was reviewed as part of the investigation.Section 4.5.3 of the ifu was found to include instructions and/or warnings relevant to the reported event.No deficiencies in the ifu that would have contributed to the complaint were identified.Investigation of this case revealed no findings available and insufficient information regarding a specific medical device problem or 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: 50952086
• Report Number: 3019004087-2026-68483
• Device Sequence Number: 9552248
• 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: Study,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: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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: Dexcom G6 CGM
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female