BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 22994008 · Received September 8, 2025

    Report

    Report Number
    3019004087-2025-02297
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BETA BIONICS ORGANIZATION
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE USER REPORTED THAT THEY EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE OF 54 MG/DL AND WERE ADMITTED TO THE HOSPITAL FOR TWO DAYS. THE USER WAS TREATED FOR LOW BLOOD GLUCOSE DURING THE HOSPITALIZATION, AND THE ILET DEVICE WAS REMOVED AND NOT RESTARTED. ATTEMPTS WERE MADE TO GATHER ADDITIONAL DETAILS, BUT THE USER DECLINED TO PROVIDE FURTHER INFORMATION. (B)(6) TO BETA BIONICS, INC ONLY SENT AN EMAIL. (B)(6) 2025 AT 11:59 AM. EMAIL TO: SUPPORT, (B)(6) "I CALLED PATIENT FOR DAY 7 FOLLOW UP #2 TODAY (B)(6) 2025, AND SHE STATED THAT SHE HAS BEEN OFF ILET SINCE 2ND DAY OF WEAR. SHE WAS CONCERNED BECAUSE IT RAN OUT OF INSULIN WITHIN THAT TIME AND SHE CALLED HER DR OFFICE AND THEY TOLD HER TO GO TO ER. SHE WAS ADMITTED X 2 DAYS AFTER GETTING THERE AND ILET WAS TAKEN OFF AND NOT PUT BACK ON. SHE STATED THAT SHE ALREADY HAD SPOKEN TO 2 PEOPLE TO REPORT THIS. WHEN I LOOKED INTO SALESFORCE, THERE WERE NO CASES OPENED. SHE WEIGHS 313 LBS. AND, IN HER REPORT, SHE MADE 2 ANNOUNCEMENTS FOR A MEAL AFTER STARTING ILET, AND THEN ANOTHER DOUBLE MEAL ANNOUNCEMENT LATER THAT DAY. ILET ADAPTED TO 72 UNITS OF BASAL, SO CLINICALLY SPEAKING THE DOSING SEEMS VERY WEIGHT BASED APPROPRIATE. SHE STATED THAT HER BG AT ER WAS 54MG/DL, SO THEY ASSUMED THAT SHE HAD BEEN DELIVERED THE ENTIRE CARTRIDGE OF REMAINING INSULIN. ALL I SAID TO HER WAS THAT SOMEONE FROM CUSTOMER CARE WOULD CALL HER TO GATHER INFORMATION. SHE ALSO STATED THAT SOMEONE AT THE DR¿S OFFICE TOLD HER THEY DID NOT ORDER THE ILET PUMP. I SENT THIS FOLLOW-UP #2 BACK TO LEE CLEVELAND SINCE SHE WAS OFF PRODUCT. BEST REGARDS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467219 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS ORGANIZATION BB1001 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization DEXCOM G7 CONTINUOUS GLUCOSE MONITOR