ILET BIONIC PANCREAS
Report
- Report Number
- 3019004087-2025-14060
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- December 1, 2025
- Report Date
- December 16, 2025
- Manufacturer
- BETA BIONICS INC.
- Product Code
- QFG
- UDI-DI
- 00850050080190
- PMA / PMN Number
- K231485
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION DESCRIPTION. COMPLAINT WAS CONFIRMED. ALERT 41 WAS PRESENT IN THE NOTIFICATIONS MENU. ENGINEERING LOGS CONFIRMED THE ALERT 41. THE DEVICE WAS OPENED TO INSPECT INTERIOR COMPONENTS. THE ISSUE WAS DUE TO FALSE HOMING.
IT WAS REPORTED THAT THE ILET DISPLAYED A RESTART ALERT, AND THE USER SHUT THE DEVICE DOWN VIA THE MENU AS INSTRUCTED; A REPLACEMENT DEVICE WAS ARRANGED AND THE USER WAS ADVISED THAT DATA WOULD NOT TRANSFER AND THAT A FULL STARTUP WOULD BE REQUIRED. SYMPTOMS INCLUDED NO ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED CONTINUED THERAPY MANAGEMENT USING THE DEXCOM G7 APP OR RECEIVER AND PLANS TO RETURN THE ORIGINAL DEVICE WITH A PROVIDED SHIPPING LABEL. INVESTIGATION INCLUDED CUSTOMER INTERVIEW AND DEVICE REPLACEMENT LOGISTICS REVIEW. INVESTIGATION OF THIS CASE REVEALED NO REPORTED INJURY, AND THE PUMP WAS OPERATIONAL ENOUGH TO ACCESS THE SHUTDOWN FUNCTION. IT WAS CONCLUDED THAT THE EVENT INVOLVED AN ALERT AND DEVICE RESTART BEHAVIOR WITHOUT PATIENT HARM, WITH MITIGATION THROUGH SHUTDOWN, REPLACEMENT, AND RETURN OF THE ORIGINAL UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79621 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS INC. | 00850050080190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Unknown |