MAUDE Adverse Event Report: BETA BIONICS INC. ILET BIONIC PANCREAS; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	BB1001
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a user was awakened by a perceived low alert, though review of the ilet graph showed a single low glucose reading of 68 mg/dl for approximately five minutes with immediate return to range, and pump history showed no urgent low alert.Symptoms included no reported adverse clinical effects.Outcomes included no need for backup therapy, no ketone testing, and no medical intervention.Investigation included a review of device data and user interview for troubleshooting and education.Investigation of this case revealed no device malfunction or alarm fault, and the cause of the transient low reading and perceived alert was unclear.It was concluded, based on previously established findings for similar reports, that the cause was indeterminate.
Additional Manufacturer Narrative
This mdr is part of a remedial submission made in response to fda form 483 observations to ensure full reporting compliance.

• 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 ; 9492888350
• MDR Report Key: 24094990
• Report Number: 3019004087-2026-22358
• Device Sequence Number: 9201574
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BB1001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 83 YR
• Patient Sex: Unknown