ILET BIONIC PANCREAS
Report
- Report Number
- 3019004087-2026-48462
- Event Type
- Malfunction
- Date Received
- May 26, 2026
- Date of Event
- May 20, 2026
- Report Date
- May 26, 2026
- Manufacturer
- BETA BIONICS, INC.
- Product Code
- QFG
- UDI-DI
- 00850050080206
- PMA / PMN Number
- K231485
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
INITIAL.
IT WAS REPORTED THAT THE USER EXPERIENCED AN ¿UNABLE TO PROCEED¿ ALERT IDENTIFIED AS A MOTOR STALL DURING A SUPPLY CHANGE, AFTER WHICH A DRY RUN WITHOUT SUPPLIES WAS SUCCESSFUL AND A SUBSEQUENT SUPPLY CHANGE WITH NEW COMPONENTS ALLOWED DELIVERY TO RESUME; THE USER REPORTED LOT NUMBERS FOR CONNECTOR 862177262, CARTRIDGES 32492, AND INSET 6011055. SYMPTOMS INCLUDED NO REPORTED ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED NO INTERRUPTION IN THERAPY BEYOND THE TRANSIENT EVENT AND NO MEDICAL INTERVENTION. INVESTIGATION INCLUDED GUIDED TROUBLESHOOTING, REMOVAL OF ALL SUPPLIES, A SUCCESSFUL DRY RUN, AND REINSTALLATION OF NEW SUPPLIES WITH SUCCESSFUL RESUMPTION OF INSULIN DELIVERY. INVESTIGATION OF THIS CASE REVEALED THAT THE CONSECUTIVE STALLED MOTOR CONDITION WAS NOT REPRODUCED AFTER RESEATING AND REPLACING DISPOSABLE COMPONENTS, CONSISTENT WITH A TRANSIENT SUPPLY OR INSTALLATION ISSUE AFFECTING THE DELIVERY MECHANISM. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS INCONCLUSIVE BUT CONSISTENT WITH INCORRECT OR INCOMPLETE SETUP THAT RESOLVED WITH PROPER REINSTALLATION. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185364 | ILET BIONIC PANCREAS | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. | 00850050080206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |