FDA Adverse Event
Malfunction
Summary report: N
ILET BIONIC PANCREAS
MDR report key: 22899100
·
Received August 26, 2025
Report
- Report Number
- 3019004087-2025-01381
- Event Type
- Malfunction
- Date Received
- August 26, 2025
- Date of Event
- July 27, 2025
- Report Date
- August 26, 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
IT WAS REPORTED THAT A BETA BIONICS ILET USER'S BLOOD GLUCOSE (BG) FLUCTUATED FROM 35 TO 753 MG/DL. THE USER HAS BEEN EATING AND MEAL ANNOUNCING WHEN BG IS ALREADY ELEVATED FOR AN EXTENDED PERIOD OF TIME LEADING TO HYPOGLYCEMIA. RECOMMENDATIONS WERE DISCUSSED WITH THE USER'S DAUGHTER. DURING THE LOW THE USER FELT DIZZY BUT NO SYMPTOMS WHEN BG WAS HIGH. THE HYPERGLYCEMIA WAS TREATED BY STAYING ON THE ILET. THE USER'S DAUGHTER ASSISTED OUT OF KINDNESS, AND NO FURTHER INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2779400 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS INC. | BB1001 | 850050080015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Other |