FDA Adverse Event Injury Summary report: N

ILET BIONIC PANCREAS

MDR report key: 21612190 · Received March 14, 2025

Report

Report Number: 3019004087-2025-00205
Event Type: Injury
Date Received: March 14, 2025
Date of Event: February 8, 2025
Report Date: March 14, 2025
Manufacturer: BETA BIONIC, INC.
Product Code: QFG
UDI-DI: 850050080015
PMA / PMN Number: K231485
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem · 0

ON (B)(6) 2025, THE USER REPORTED A HYPOGLYCEMIC EVENT CAUSED BY INSERTING AN INSULIN CARTRIDGE WITHOUT REWINDING THE PISTON, RESULTING IN UNINTENDED DOSE OF INSULIN CAUSING THE USERS BLOOD GLUCOSE (BG) TO DROP BELOW 54 MG/DL FOR APPROXIMATELY 5 HOURS. THE USER MANAGED HYPOGLYCEMIA BY CONSUMING SUGAR WITH ASSISTANCE FROM THEIR SISTER BUT DID NOT CONTACT THEIR HCP OR BETA BIONICS. A FOLLOW-UP VIRTUAL TRAINING SESSION WAS CONDUCTED ON (B)(6) 2025 WITH THE USER AND CERTIFIED DIABETES CARE AND EDUCATION SPECIALIST (CDCES). DURING THE TRAINING, THE USER DEMONSTRATED UNDERSTANDING OF PROPER CARTRIDGE CHANGE PROCEDURES AND COMMITTED TO PERFORMING INFUSION SET AND CARTRIDGE CHANGES WITH ASSISTANCE FROM HIS SISTER. THE USER REPORTED IMPROVED TIME IN RANGE AND BETTER MANAGEMENT OF THE DEVICE FOLLOWING RE-EDUCATION. NO LONG-TERM HEALTH EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
900380	ILET BIONIC PANCREAS	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP	QFG	BETA BIONIC, INC.	BB1001		850050080015

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR	Male	Required Intervention	DEXCOM G7 CONTINUOUS GLUCOSE MONITOR.