FDA Adverse Event
Malfunction
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 23018120
·
Received September 10, 2025
Report
- Report Number
- 3019004087-2025-02486
- Event Type
- Malfunction
- Date Received
- September 10, 2025
- Date of Event
- August 14, 2025
- Report Date
- September 10, 2025
- Manufacturer
- BETA BIONICS INC.
- Product Code
- QFG
- UDI-DI
- 850050080015
- PMA / PMN Number
- K231485
- Product Problem
- 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 (B)(6) 2025 THE USER REPORTED THEY WERE UNABLE TO REMOVE THE CONNECTOR FROM THE PUMP WHEN TROUBLESHOOTING AN RESTART ALERT. A DEVICE REPLACEMENT WAS ARRANGED. THE USER CONFIRMED THAT BLOOD GLUCOSE LEVELS WERE NOT AFFECTED, AND NO SYMPTOMS OR ADVERSE EVENTS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1778272 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS INC. | BB1001 | 850050080015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | ILET CONNECT ADAPTER. |