ILET BIONIC PANCREAS
Report
- Report Number
- 3019004087-2026-44363
- Event Type
- Malfunction
- Date Received
- April 28, 2026
- Date of Event
- April 12, 2026
- Report Date
- April 28, 2026
- Manufacturer
- BETA BIONICS, INC.
- Product Code
- QFG
- UDI-DI
- 850050080077
- PMA / PMN Number
- K231485
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
INITIAL.
IT WAS REPORTED THAT AN ILET USER EXPERIENCED AN INSULIN DELIVERY OCCLUSION WITH A REPORTED BLOOD GLUCOSE VALUES AND TRENDED FROM 219 TO THE 230¿256 MG/DL RANGE ON AN INFUSION SET THAT INITIALLY CLEARED AFTER PRESSING THE PUMP BUTTON, FOLLOWED BY A DOSING STOPPED ALERT SHORTLY AFTER A MEAL BOLUS; DESPITE RESUMED DELIVERY, AND THE USER CHANGED THE CARTRIDGE, ADAPTOR, AND SET, WITH FILL-TUBING CONFIRMING DROPS AND NO OBSERVED LEAKS OR KINKS, CONSISTENT WITH A COMPLETE BLOCKAGE IN THE TUBING COMPONENT. NO ADVERSE CLINICAL SYMPTOMS ASSOCIATED WITH HYPERGLYCEMIA REPORTED. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED A COMMUNICATIONS-RELATED PROBLEM WAS IDENTIFIED IN RELATION TO INSULIN DELIVERY INTERRUPTION AND THAT THE ISSUE ALIGNED WITH A DEVICE PROBLEM OF COMPLETE BLOCKAGE LOCALIZED TO THE TUBE COMPONENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS TRACED TO COMPONENT FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618086 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | BB3001 | 850050080077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | CONVATEC INFUSION SET - INSET |