BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24056998 · Received January 13, 2026

    Report

    Report Number
    3019004087-2026-21539
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    October 16, 2025
    Report Date
    January 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

    THE USER EXPERIENCED HYPOGLYCEMIA REQUIRING EMERGENCY MEDICAL SERVICES TRANSPORT WHILE RECEIVING AUTOMATED INSULIN DELIVERY WITH THE ILET. THIS SITUATION CAN RESULT IN SEVERE HYPOGLYCEMIA REQUIRING MEDICAL INTERVENTION AND IS CONSISTENT WITH THE REPORTED LOW BLOOD GLUCOSE AND EMERGENCY TRANSPORT FROM THE ASSISTED LIVING FACILITY. AVAILABLE INFORMATION INDICATES THE ILET WAS REMOVED UPON HOSPITAL ADMISSION AND WAS SUBSEQUENTLY LOST DURING THE COURSE OF CARE. THE PROLONGED HOSPITALIZATION WAS REPORTED TO BE RELATED TO TREATMENT OF INFECTIONS FROM PRE-EXISTING FOOT WOUNDS AND NOT ATTRIBUTED TO THE HYPOGLYCEMIC EVENT. DUE TO LIMITED INFORMATION PROVIDED BY A THIRD PARTY AND THE UNAVAILABILITY OF THE DEVICE FOR EVALUATION, THE SPECIFIC CAUSE OF THE HYPOGLYCEMIC EVENT COULD NOT BE DETERMINED, AND NO DEVICE MALFUNCTION WAS IDENTIFIED BASED ON AVAILABLE RECORDS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 08-JAN-2026 IT WAS REPORTED THAT ON (B)(6) 2025 THE USER EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE (BG) LEVELS REPORTED AS LOW AS 39 MG/DL WHILE RESIDING IN AN ASSISTED LIVING FACILITY. THE USER WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES TO THE HOSPITAL, WHERE THE ILET WAS REMOVED UPON ARRIVAL AND THE USER REMAINED HOSPITALIZED FROM (B)(6) 2025 TO (B)(6) 2025 FOR TREATMENT OF MEDICAL CONDITIONS UNRELATED TO THE HYPOGLYCEMIC EVENT. NO LONG-TERM HEALTH EFFECTS RELATED TO THE HYPOGLYCEMIC EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117551 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Hospitalization DEXCOM G7 CONTINUOUS GLUCOSE MONITOR