BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 21627441 · Received March 17, 2025

    Report

    Report Number
    3019004087-2025-00219
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BETA BIONIC, INC.
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON 21-FEB-2025, THE MANUFACTURER WAS NOTIFIED THAT A USER EXPERIENCED SEVERE HYPOGLYCEMIA ON (B)(6) 2025, RESULTING IN WEAKNESS, COLDNESS, SHAKINESS, AND LETHARGY. THE USER'S BLOOD GLUCOSE (BG) DROPPED TO 39 MG/DL AND REMAINED "LOW" (UNDER 54 MG/DL) FOR APPROXIMATELY NINE HOURS. THE USER ATTEMPTED TO OBTAIN ORANGE JUICE (OJ) BUT WAS TOO WEAK TO MOVE AND CALLED A NEIGHBOR, WHO THEN CONTACTED THE USER'S CHILDREN. EMS ARRIVED, ADMINISTERED OJ, AND TRANSPORTED THE USER TO THE EMERGENCY ROOM (ER). THE USER WAS GIVEN ORAL GLUCOSE AT THE HOSPITAL AND DISCHARGED ONCE BG LEVELS INCREASED. THE USER REPORTED THAT THE DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM) DID ALERT FOR LOW BG DURING THE EVENT. NO LONG-TERM HEALTH EFFECTS WERE REPORTED, AND THE USER RESUMED USE OF THE ILET FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884672 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONIC, INC. BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention DEXCOM G7 CONTINUOUS GLUCOSE MONITOR