ILET BIONIC PANCREAS
Report
- Report Number
- 3019004087-2025-00614
- Event Type
- Death
- Date Received
- June 27, 2025
- Date of Event
- May 25, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BETA BIONICS, 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
NO PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING RELEASE CRITERIA FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. AT THE TIME OF THIS REPORT, THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
ON 27-MAY-2025, A CERTIFIED DIABETES CARE AND EDUCATION SPECIALIST (CDCES) NOTIFIED BETA BIONICS THAT THE USER HAD PASSED AWAY OVER THE WEEKEND. FOLLOW-UP ON (B)(6) 2025 CONFIRMED THE USER PASSED AWAY ON (B)(6) 2025. AT THE TIME OF DISCOVERY, THE USER WAS WEARING THE ILET, BUT THE INFUSION SET WAS FOUND TO BE PARTIALLY DISLODGED. THE REPORTED CAUSE OF DEATH WAS NATURAL CAUSES AND HIGH BLOOD PRESSURE. NO AUTOPSY WAS PERFORMED. REVIEW OF DEVICE DATA CONFIRMS THE ILET WAS IN USE THROUGH (B)(6) 2025. A DEVICE INVESTIGATION IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE EVALUATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974450 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC | BB1001 | 850050080015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Death | CONVATEC CONTACT DETACH (23", 6MM)| DEXCOM G7 CONTINUOUS GLUCOSE MONITOR |