FDA Adverse Event
Injury
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 23263187
·
Received October 10, 2025
Report
- Report Number
- 3019004087-2025-04727
- Event Type
- Injury
- Date Received
- October 10, 2025
- Date of Event
- September 11, 2025
- Report Date
- October 9, 2025
- Manufacturer
- BETA BIONICS INC
- Product Code
- QFG
- PMA / PMN Number
- K231485
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 0
ON 09/11/2025, THE USER¿S CAREGIVER REPORTED THAT THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE (¿HIGH¿ ON ILET, FINGERSTICK 419 MG/DL) AFTER THE INFUSION SITE WAS ACCIDENTALLY REMOVED. THE USER REPLACED THE SITE AND CARTRIDGE BEFORE CONTACTING BETA BIONICS. A MEAL HAD BEEN ANNOUNCED SHORTLY BEFORE THE EVENT. FOLLOW-UP CONFIRMED BG 317 MG/DL AND TRENDING DOWN. THE USER WAS COMFORTABLE AND REQUIRED NO MEDICAL CARE. NO LEAKS, KINKS, OR DEVICE ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2059666 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | BETA BIONICS INC | BB2001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Other |