FDA Adverse Event Malfunction Summary report: N

ILET BIONIC PANCREAS

MDR report key: 24465371 · Received February 26, 2026

Report

Report Number: 3019004087-2026-33698
Event Type: Malfunction
Date Received: February 26, 2026
Date of Event: June 3, 2025
Report Date: February 26, 2026
Manufacturer: BETA BIONICS INC.
Product Code: QFG
UDI-DI: 00850050080183
PMA / PMN Number: K231485
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN THE USER UNLOCKED THE ILET, THE DEVICE DISPLAYED THE REWIND PROMPT AND THEN RETURNED TO THE BLOOD GLUCOSE DISPLAY, WHICH THE AGENT ASSESSED AS LIKELY DUE TO INADVERTENT NAVIGATION TO THE REWIND MENU PRIOR TO SLEEP; BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 192 MG/DL AFTER BREAKFAST, AND THERAPY WAS NOT IMPACTED. SYMPTOMS INCLUDED NO ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED NO CHANGE IN THERAPY, NO MEDICAL INTERVENTION, AND NO HOSPITALIZATION. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION BY CUSTOMER CARE. INVESTIGATION OF THIS CASE REVEALED NO DEVICE MALFUNCTION AND SUGGESTED USER INTERACTION WITH THE MENU AS THE LIKELY CONTRIBUTOR, WITH NO IDENTIFIED COMPONENT FAILURE. 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
512107	ILET BIONIC PANCREAS	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONICS INC.	BB1001		00850050080183

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR	Unknown