FDA Adverse Event Malfunction Summary report: N

ILET BIONIC PANCREAS

MDR report key: 24476925 · Received February 27, 2026

Report

Report Number: 3019004087-2026-34023
Event Type: Malfunction
Date Received: February 27, 2026
Date of Event: June 26, 2025
Report Date: February 27, 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

MANUFACTURER REVIEW DETERMINED THAT THE REPORTED EVENT IS CONSISTENT WITH A PREVIOUSLY IDENTIFIED AND WELL-CHARACTERIZED FAILURE MODE THAT HAS BEEN DOCUMENTED IN PRIOR COMPLAINTS AND INVESTIGATIONS FOR THIS DEVICE. THE FAILURE MECHANISM AND ASSOCIATED POTENTIAL HARMS ARE ALREADY KNOWN AND HAVE BEEN EVALUATED THROUGH EARLIER INVESTIGATIONS. 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 AN ILET A111120 HAD A CRACKED SCREEN, AND HARDWARE TROUBLESHOOTING AND EDUCATION WERE COMPLETED WITH A REPLACEMENT DEVICE PROVIDED WHILE THE ORIGINAL WAS PENDING RETURN. SYMPTOMS INCLUDED NO ALERTS OR ALARMS. OUTCOMES INCLUDED CONTINUED THERAPY WITHOUT CLINICAL IMPACT. INVESTIGATION INCLUDED CUSTOMER TROUBLESHOOTING AND EDUCATION. INVESTIGATION OF THIS CASE REVEALED SCREEN DAMAGE CONSISTENT WITH PHYSICAL IMPACT TO THE DISPLAY ASSEMBLY, WITH NO EVIDENCE OF ALERT OR ALARM MALFUNCTION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS MECHANICAL DAMAGE DUE TO HANDLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383491	ILET BIONIC PANCREAS	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONICS INC.	BB1001		00850050080183

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR	Unknown