BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24323739 · Received February 12, 2026

    Report

    Report Number
    3019004087-2026-29185
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    April 28, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    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 A USER AWOKE TO A LOW GLUCOSE READING OF 69 MG/DL, INGESTED A GRANOLA BAR WITH APPROXIMATELY 22¿23 GRAMS OF CARBOHYDRATES, THEN EXPERIENCED A SUBSEQUENT GLUCOSE RISE TO 200¿260 MG/DL; THE USER QUESTIONED THE INITIAL LOW DUE TO RAPID RISE AND WAS EDUCATED ON POTENTIAL COMPRESSION LOWS, CONFIRMATION BY FINGERSTICK, CORRECTION ALGORITHMS, AND ALLOWING THE ILET TO MANAGE THE HIGH. SYMPTOMS INCLUDED AN ASYMPTOMATIC LOW GLUCOSE READING WITHOUT ACUTE CLINICAL EFFECTS. OUTCOMES INCLUDED SELF-TREATMENT WITH ORAL CARBOHYDRATE, TRANSIENT HYPERGLYCEMIA FOR ABOUT 30 MINUTES, USE OF DEVICE-DRIVEN CORRECTION, NO NEED FOR ASSISTANCE, AND NO MEDICAL INTERVENTION. INVESTIGATION INCLUDED REVIEW OF DEVICE USE, TROUBLESHOOTING, AND USER EDUCATION REGARDING ALERTS, COMPRESSION LOWS, AND APPROPRIATE CORRECTION PRACTICES. INVESTIGATION OF THIS CASE REVEALED NO EVIDENCE OF DEVICE MALFUNCTION OR SUPPLY ISSUES, GLUCOSE VALUES WERE GENERALLY IN RANGE OUTSIDE THE EVENT, AND THE HYPERGLYCEMIA WAS CONSISTENT WITH USER OVERCORRECTION OF THE SUSPECTED LOW. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR WITH USER-RELATED OVERCORRECTION SUSPECTED AND NO DEVICE FAULT IDENTIFIED. 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
    381972 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other