FDA Adverse Event
Injury
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 23175579
·
Received September 29, 2025
Report
- Report Number
- 3019004087-2025-03819
- Event Type
- Injury
- Date Received
- September 29, 2025
- Date of Event
- September 1, 2025
- Report Date
- September 29, 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 01-SEP-2025, IT WAS REPORTED THAT A BETA BIONICS ILET USER EXPERIENCED A HYPERGLYCEMIC EPISODE WITH A BLOOD GLUCOSE VALUE OF 264 MG/DL. THE EVENT WAS ADDRESSED BY PERFORMING AN INFUSION SITE CHANGE AND CONTINUING INSULIN DELIVERY. NO OUTSIDE MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2145307 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | BB1001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DEXCOM G7 CONTINUOUS GLUCOSE MONITOR. |