ILET BIONIC PANCREAS
Report
- Report Number
- 3019004087-2026-44192
- Event Type
- Malfunction
- Date Received
- April 27, 2026
- Date of Event
- April 2, 2026
- Report Date
- April 27, 2026
- 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
INITIAL.
IT WAS REPORTED THAT A USER EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE READINGS ABOVE 300 MG/DL, PEAKING AT 361 MG/DL BY SENSOR AND 348 MG/DL BY FINGERSTICK, WHILE USING THE ILET; THE USER HAD NOT EATEN OR DRUNK, THE PUMP WAS DELIVERING INSULIN PER SYNCED DATA, SUPPLIES HAD BEEN CHANGED TWO DAYS PRIOR WITH APPROXIMATELY 60 UNITS REMAINING, AND THE USER WAS ADVISED ON INFUSION SITE ROTATION AND PROCEEDED WITH A SUPPLY CHANGE AND A NEW SITE ON THE FLANK, AFTER WHICH GLUCOSE DECREASED TO APPROXIMATELY 250¿263 MG/DL. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER OR THIRD PARTY. INVESTIGATION OF THIS CASE REVEALED NO FINDINGS AVAILABLE, AND THERE WAS INSUFFICIENT INFORMATION TO DETERMINE A SPECIFIC MEDICAL DEVICE PROBLEM OR DEVICE COMPONENT INVOLVEMENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS NOT ESTABLISHED. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206080 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | BB1001 | 850050080015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male |