FDA Adverse Event Malfunction Summary report: N

ILET BIONIC PANCREAS

MDR report key: 24722990 · Received March 30, 2026

Report

Report Number
3019004087-2026-39966
Event Type
Malfunction
Date Received
March 30, 2026
Date of Event
March 7, 2026
Report Date
March 27, 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 A CAREGIVER REQUESTED ASSISTANCE WITH AN ILET SUPPLY CHANGE, COMPLETED THE PROCEDURE SUCCESSFULLY, AND SUBSEQUENTLY OBSERVED HIGH GLUCOSE READINGS ON THE PUMP; A CONFIRMATORY FINGERSTICK MEASURED 361 MG/DL, WHICH WAS ENTERED FOR CALIBRATION, AND LATER A FOLLOW-UP READING WAS 296 MG/DL AFTER ASSIGNMENT TO AN ADVANCED TROUBLESHOOTING RESOURCE AND EDUCATION ON CONSISTENT MEAL TIMING. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED ONGOING MONITORING AT HOME WITHOUT MEDICAL INTERVENTION OR HOSPITALIZATION. INVESTIGATION INCLUDED USER GUIDANCE, REVIEW OF INFUSION SET HANDLING AND DISCONNECTIONS, CALIBRATION STEPS, AND EDUCATION ON MEAL SPACING. INVESTIGATION OF THIS CASE REVEALED THAT RECURRENT DISCONNECTIONS AND PAUSES COULD CONTRIBUTE TO ELEVATED GLUCOSE, WITH NO DEVICE MALFUNCTION REPORTED OR IDENTIFIED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
788015 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 850050080015

Patients

Seq Age Sex Outcome Treatment
1 14 YR Male