FDA Adverse Event
Injury
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 22998435
·
Received September 8, 2025
Report
- Report Number
- 3019004087-2025-02315
- Event Type
- Injury
- Date Received
- September 8, 2025
- Date of Event
- August 6, 2025
- Report Date
- September 8, 2025
- Manufacturer
- BETA BIONICS, INC.
- Product Code
- QFG
- UDI-DI
- 850050080015
- 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 EXPERIENCED A HYPOGLYCEMIC EVENT THAT RESULTED IN A SEIZURE. REVIEW OF REPORTS INDICATED THREE LATE MEAL ANNOUNCEMENTS ON (B)(6) 2025 CONTRIBUTED TO THE LOW BLOOD GLUCOSE EVENT. SEVEN FOLLOW-UP ATTEMPTS WERE MADE WITH THE CAREGIVER, SOCIAL WORKER, AND USER TO GATHER ADDITIONAL DETAILS, BUT NO FURTHER CLINICAL INFORMATION WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2068664 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | BB1001 | 850050080015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DEXCOM G7 CONTINUOUS GLUCOSE MONITOR. |