FDA Adverse Event Malfunction Summary report: N

ILET BIONIC PANCREAS

MDR report key: 23953635 · Received January 3, 2026

Report

Report Number
3019004087-2026-19055
Event Type
Malfunction
Date Received
January 3, 2026
Date of Event
January 2, 2026
Report Date
January 3, 2026
Manufacturer
BETA BIONICS INC.
Product Code
QFG
UDI-DI
850050080015
PMA / PMN Number
K231485
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT THE USER ATTEMPTED TO ANNOUNCE A MEAL AND RECEIVED AN ¿UNABLE TO PROCEED, PLEASE CHECK BACK IN 5 MINUTES¿ MESSAGE, AFTER WHICH TUBING FLOW WAS CONFIRMED, THE CANNULA WAS FILLED, INSULIN DELIVERY WAS RESUMED, AND DATA WERE SYNCED, REVEALING TWO PRIOR MEAL ANNOUNCEMENTS WITHIN ABOUT TWENTY MINUTES AND APPROXIMATELY 8 UNITS OF INSULIN ON BOARD. SYMPTOMS INCLUDED RISK FOR HYPOGLYCEMIA GIVEN CUMULATIVE INSULIN DOSING, WITH THE USER ADVISED TO CONSUME ADDITIONAL FOOD; THE BLOOD GLUCOSE AT THE END OF THE CALL WAS 183 MG/DL. OUTCOMES INCLUDED USER EDUCATION ON INSULIN ON BOARD AND MEAL ANNOUNCEMENT TIMING, WITH RECOMMENDATION TO INGEST A MORE SUBSTANTIAL CARBOHYDRATE SOURCE TO MITIGATE POTENTIAL RAPID GLUCOSE DECLINE. INVESTIGATION INCLUDED REVIEW OF DEVICE DATA, VERIFICATION OF INFUSION SET FUNCTION, CONFIRMATION OF RESUMED INSULIN DELIVERY, AND ASSESSMENT OF RECENT MEAL ENTRIES AND INSULIN ON BOARD. INVESTIGATION OF THIS CASE REVEALED MULTIPLE MEAL ANNOUNCEMENTS OVER A SHORT INTERVAL LEADING TO HIGHER THAN TYPICAL INSULIN ON BOARD, WHILE THE INFUSION SET AND DELIVERY PATHWAY APPEARED FUNCTIONAL AND INSULIN DELIVERY WAS CONFIRMED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT USER INTERACTION RESULTING IN DUPLICATE MEAL ANNOUNCEMENTS AND CUMULATIVE INSULIN DOSING WAS THE LIKELY CAUSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
14890 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

Patients

Seq Age Sex Outcome Treatment
1 85 YR Male