FDA Adverse Event Malfunction Summary report: N

K231485

MDR report key: 23386622 · Received October 25, 2025

Report

Report Number: 3019004087-2025-05857
Event Type: Malfunction
Date Received: October 25, 2025
Date of Event: September 24, 2025
Report Date: October 24, 2025
Manufacturer: BETA BIONICS, INC.
Product Code: QFG
UDI-DI: 850050080015
PMA / PMN Number: (01)85005008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION INCLUDED COMPLAINT HANDLING, USER EDUCATION, AND TROUBLESHOOTING GUIDANCE PROVIDED REMOTELY. INVESTIGATION OF THIS CASE REVEALED NO CONFIRMED DEVICE MALFUNCTION AND A PROBABLE USER-RELATED FACTOR CONSISTENT WITH OVERCORRECTION OF HYPOGLYCEMIA LEADING TO REBOUND HYPERGLYCEMIA. IT WAS CONCLUDED THAT THE EVENT WAS CONSISTENT WITH HYPERGLYCEMIA OF UNCLEAR CAUSE WITH NO EVIDENCE OF DEVICE FAILURE. THE DEVICE HAS NOT BEEN RETURNED. IF IT IS RETURNED, IT WILL BE EVALUATED, AND A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 0

IT WAS REPORTED THAT A USER EXPERIENCED HYPERGLYCEMIA WHILE USING THE ILET BIONIC PANCREAS IN CONJUNCTION WITH A DEXCOM G7, AFTER SELF-REPORTING A PRIOR LOW GLUCOSE EPISODE THAT THEY OVERTREATED; THE USER OBSERVED A HIGH ILET READING, PERFORMED A CONFIRMATORY FINGERSTICK SHOWING ELEVATED GLUCOSE, INSERTED A NEW INFUSION SITE, ADMINISTERED 3 UNITS OF BACKUP INSULIN OFF-PUMP, DISCONNECTED FROM THE ILET, AND LATER RECONNECTED ONCE GLUCOSE RETURNED TO RANGE. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE. OUTCOMES INCLUDED TEMPORARY USE OF BACKUP INSULIN THERAPY AND RESTORATION OF GLUCOSE TO TARGET WITHOUT MEDICAL INTERVENTION OR HOSPITALIZATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2027977	K231485	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONICS, INC.	BB1001		850050080015

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR	Unknown		DEXCOM G7 CONTINUOUS GLUCOSE MONITOR