BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23781406 · Received December 11, 2025

    Report

    Report Number
    3019004087-2025-12753
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 4, 2024
    Report Date
    December 11, 2025
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Product Problem
    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 AN INPATIENT USING AN ILET WITH DEXCOM G6 EXPERIENCED HYPOGLYCEMIA WHILE NPO FOR A PLANNED CARDIAC PROCEDURE, WITH A REPORTED LOWEST GLUCOSE OF 54 MG/DL CONFIRMED BY HOSPITAL METER AND CGM; STAFF ADJUSTED THE DEXCOM LOW ALERT, AND THE PATIENT RECEIVED DEXTROSE INTRAVENOUSLY FOLLOWED BY ORANGE AND CRANBERRY JUICE, RESULTING IN RECOVERY. SYMPTOMS INCLUDED SHAKINESS. OUTCOMES INCLUDED DELAY OF THE PLANNED PROCEDURE. INVESTIGATION INCLUDED AGENT FOLLOW-UP, REVIEW OF USER STATEMENTS, AND TROUBLESHOOTING AND EDUCATION THAT THE ILET IS NOT INTENDED FOR USE IN A HOSPITAL SETTING; THE EVENT DURATION OUTSIDE TARGET WAS ABOUT ONE HOUR, AND NO KETONE TESTING OR STEROID USE WAS REPORTED. INVESTIGATION OF THIS CASE REVEALED NO CONFIRMED DEVICE MALFUNCTION AND AN UNCLEAR CAUSE, WITH POTENTIAL CONTRIBUTING FACTORS INCLUDING NPO STATUS, CONCURRENT HOSPITAL TESTING, AND THE INPATIENT SETTING. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS INCONCLUSIVE. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797466 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown