BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24539947 · Received March 7, 2026

    Report

    Report Number
    3019004087-2026-36023
    Event Type
    Malfunction
    Date Received
    March 7, 2026
    Date of Event
    July 23, 2024
    Report Date
    March 7, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND EVALUATED BY BETA BIONICS. USER COMPLAINT OF DEVICE MALFUNCTION WAS CONFIRMED VIA FAILURE INVESTIGATION. THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER EXPERIENCED PERSISTENT ALERT 60 INDICATING A BLUETOOTH COMMUNICATIONS ERROR ON THE ILET DESPITE MULTIPLE RESTARTS, AND A REPLACEMENT DEVICE WAS ARRANGED; BLOOD GLUCOSE WAS NOT AFFECTED. SYMPTOMS INCLUDED NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. THE DEVICE WAS RETURNED FOR EVALUATION. PRELIMINARY INVESTIGATION OF THIS CASE REVEALED SIGNAL LOSS CONSISTENT WITH A FAILURE TO READ AN INPUT SIGNAL, TRACED TO THE CIRCUIT BOARD RESPONSIBLE FOR BLUETOOTH COMMUNICATIONS. THE DEVICE POWERS UP WHEN PLACED ON THE CHARGER. THE ALARMS MENU SHOWS ALERT 60 AND WANTS A RESTART. AFTER RESTART, ALERT 60 STILLS RETURN. THE DEVICE WAS CHECKED ON THE FUKUDA LEAK TEST MACHINE EO377.001 WHERE IT FAILED. THE DEVICE WAS THE OPENED TO CHECK FOR FLUID INGRESS OR FOD. NONE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. THE CAUSE OF THE FAILURE REPORTED COULD NOT BE DETERMINED. THE BLUETOOTH CHIP U4 FAILED TO OPERATE PROPERLY. WHEN THE CHIP WAS REHEATED FOR SOLDERABILITY, IT BRIEFLY OPERATED THEN FAILED. THIS INDICATES A BAD CHIP U4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491179 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown DEXCOM G7 CGM (CONTINUOUS GLUCOSE MONITOR)