BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25247039 · Received May 21, 2026

    Report

    Report Number
    3016798778-2026-00142
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE REPORTED HYPOGLYCEMIA COULD NOT BE DETERMINED. INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT THE POTENTIAL CAUSES OF HYPOGLYCEMIA AND HOW TO PREVENT IT. THE USER GUIDE ALSO PROVIDES INFORMATION REGARDING THE WORKOUT PRESET, STATING, "WHEN YOU WOULD LIKE TO EXERCISE, USE THE WORKOUT PRESET TO TEMPORARILY RAISE YOUR CORRECTION RANGE. THE TWIIST AID SYSTEM WILL USE YOUR WORKOUT RANGE TO HELP REDUCE THE RISK OF LOW GLUCOSE EVENTS." AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 21-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT WHILE WORKING IN THE YARD ON (B)(6) 2026, THEIR GLUCOSE VALUE DECREASED TO 25 MG/DL. THE USER WAS GIVEN A SUGAR GEL PACK AND CANNED FRUIT BY THEIR SPOUSE TO RESOLVE THE HYPOGLYCEMIA. THE USER FURTHER REPORTED THAT THEY HAD NOT BEEN USING THE TWIIST WORKOUT PRESET LEADING UP TO THE EVENT AND STATED THAT THEY WOULD USE THIS FEATURE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194995 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1