BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24961510 · Received April 23, 2026

    Report

    Report Number
    3019004087-2026-43585
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ILET PUMP WITH SERIAL NUMBER A141548 EXPERIENCED PREMATURE BATTERY DISCHARGE OVERNIGHT AFTER BEING CHARGED TO APPROXIMATELY 51 PERCENT ON A FLAT PHONE CHARGER, WOULD NOT CHARGE ON THE ILET CHARGER, AND SUBSEQUENTLY SHUT DOWN, DURING WHICH THE PATIENT¿S BLOOD GLUCOSE ROSE TO 385 MG/DL BEFORE LATER DECREASING TO 222 MG/DL WITH THE PATIENT FEELING FINE; THE REPORTED DEVICE PROBLEM INVOLVED POWER AND VERY LOW BATTERY, AND THE IMPLICATED COMPONENT WAS THE BATTERY. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER, WITH REVIEW OF ENGINEERING LOGS INDICATING THE BATTERY DEPRECIATED ABOUT 50 PERCENT IN FIVE HOURS. INVESTIGATION OF THIS CASE REVEALED AN ENERGY STORAGE SYSTEM PROBLEM CONSISTENT WITH PREMATURE DISCHARGE OF THE BATTERY, IMPLICATING THE BATTERY COMPONENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS TRACED TO A COMPONENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397403 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male