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

Model Number	BB1001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hyperglycemia (1905); Polydipsia (2604)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user¿s dexcom g7 expired and the user applied a dexcom g6 continuous glucose monitor (cgm) that was paired to the phone but not to the ilet, resulting in an extended time without cgm data on the pump and subsequent hyperglycemia; the user later entered the pairing code and successfully paired the g6 to the ilet after education on the pairing process and expected pairing time.Symptoms included hyperglycemia with a peak glucose of 502 mg/dl and associated polydipsia.Outcomes included a delay to treatment or therapy during the absence of cgm data.Investigation included communication with the user and analysis of information provided by the user.Investigation of this case revealed no device problem and identified a usage problem, specifically an improper or incorrect procedure in not following pairing instructions; no device component was applicable.It was concluded, based on previously established findings for similar reports, that the cause was failure to follow instructions and an unintended use error that contributed to the event.

• 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: 50948275
• Report Number: 3019004087-2026-68360
• Device Sequence Number: 18525208
• 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?: 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: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female