FDA Adverse Event Death Summary report: N

ILET BIONIC PANCREAS

MDR report key: 24303662 · Received February 10, 2026

Report

Report Number: 3019004087-2026-28234
Event Type: Death
Date Received: February 10, 2026
Date of Event: October 28, 2025
Report Date: February 10, 2026
Manufacturer: BETA BIONICS INC.
Product Code: QFG
UDI-DI: 00850050080183
PMA / PMN Number: K231485
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS MDR IS BEING SUBMITTED BEYOND THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYS ASSOCIATED WITH RECENT INTERNAL SYSTEM CHANGES. THE DELAY WAS UNINTENTIONAL AND HAS SINCE BEEN ADDRESSED THROUGH PROCESS AND SYSTEM UPDATES TO PREVENT RECURRENCE.

Description of Event or Problem · 0

IT WAS REPORTED THAT A USER DIED WHILE NOT USING THE ILET; THE USER HAD BRIEFLY USED THE DEVICE AFTER TRAINING AND THEN DISCONTINUED USE, AND THE FAMILY REPORTED NO CONCERNS RELATED TO THE DEVICE. SYMPTOMS INCLUDED DEATH OF UNKNOWN CAUSE. OUTCOMES INCLUDED DEATH WITH NO HOSPITALIZATION OR END-OF-LIFE CARE. INVESTIGATION INCLUDED INTERNAL REVIEW OF THE REPORT AND COLLECTION OF INFORMATION FROM THE FAMILY REGARDING DEVICE USE AT THE TIME OF DEATH. INVESTIGATION OF THIS CASE REVEALED THAT THE DEVICE WAS NOT IN USE AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR DEVICE CONTRIBUTION TO THE EVENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNRELATED TO THE DEVICE AND COULD NOT BE DETERMINED. 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
365838	ILET BIONIC PANCREAS	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONICS INC.	BB1001		00850050080183

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR	Unknown