BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24338879 · Received February 13, 2026

    Report

    Report Number
    3019004087-2026-29763
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    June 22, 2025
    Report Date
    February 13, 2026
    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

    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 WHILE ASLEEP THE USER FELT A POKE AND DISCOVERED THE INFUSION SET (CONTACT DETACH, LOT 6012677) HAD BEEN PULLED OUT, AFTER WHICH THEY PERFORMED A PROMPT SITE AND SUPPLY CHANGE AND RESUMED INSULIN DELIVERY; BLOOD GLUCOSE REACHED 240 MG/DL AND WAS OUT OF RANGE FOR OVER TWO HOURS, AND THE ILET DID NOT ALERT. SYMPTOMS INCLUDED FEELING OKAY WITHOUT CLINICAL COMPLAINTS. OUTCOMES INCLUDED TRANSIENT HYPERGLYCEMIA THAT RESOLVED AFTER THE SITE CHANGE, WITH NO NEED FOR OUTSIDE ASSISTANCE OR MEDICAL INTERVENTION. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED HYPERGLYCEMIA WITH AN UNCLEAR CAUSE ASSOCIATED WITH AN INFUSION SITE DISLODGEMENT, WITH NO ILET ALERT REPORTED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399866 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown Required Intervention