FDA Adverse Event Malfunction Summary report: N

BETA BIONICS INC

MDR report key: 24461259 · Received February 26, 2026

Report

Report Number: 3019004087-2026-33493
Event Type: Malfunction
Date Received: February 26, 2026
Date of Event: July 19, 2025
Report Date: February 26, 2026
Manufacturer: BETA BIONICS INC.
Product Code: QFG
UDI-DI: 00850050080206
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 THE USER DROPPED THE ILET AT A POOL PARTY, RESULTING IN A CRACKED AND UNRESPONSIVE TOUCHSCREEN; A REPLACEMENT DEVICE AND NEW HARD CASE WERE ARRANGED, AND THE USER REVERTED TO BACKUP THERAPY. SYMPTOMS INCLUDED EPISODES OF HYPOGLYCEMIA AND HYPERGLYCEMIA. OUTCOMES INCLUDED EFFECTS NOT FULLY CAPTURED WITHIN AVAILABLE PREDEFINED TERMS. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER, INCLUDING VIDEO. INVESTIGATION OF THIS DEVICE REVEALED A STRESS-RELATED PROBLEM ASSOCIATED WITH PHYSICAL DAMAGE TO THE TOUCHSCREEN COMPONENT, CONSISTENT WITH A FRACTURE-TYPE DEVICE PROBLEM. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS TRACED TO USER HANDLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
257122	BETA BIONICS INC	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONICS INC.	BB1001		00850050080206

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR	Unknown