FDA Adverse Event
Malfunction
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 23158581
·
Received September 26, 2025
Report
- Report Number
- 3019004087-2025-03648
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- August 29, 2025
- Report Date
- September 26, 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 (B)(6) 2025, THE USER RECEIVED A LOW BLOOD GLUCOSE (BG) ALERT DURING A SUPPLY CHANGE. THE LOWEST BLOOD GLUCOSE (BG) RECORDED WAS 66 MG/DL. THE USER TREATED THE LOW BY DRINKING MOUNTAIN DEW, WHICH CORRECTED BLOOD GLUCOSE (BG). THE USER REPORTED FEELING FINE. NO OUTSIDE ASSISTANCE OR MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303371 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | BB1001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female |