BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24742495 · Received March 31, 2026

    Report

    Report Number
    3016798778-2026-00075
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 31, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT POTENTIAL CAUSES OF HYPOGLYCEMIA, 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. FAILING TO INFORM THE TWIIST AID SYSTEM THAT YOU WOULD LIKE YOUR CORRECTION RANGE TO BE MODIFIED THROUGH THE USE OF THE WORKOUT PRESET MAY CAUSE UNEXPECTED CHANGES TO YOUR GLUCOSE TO OCCUR. ABOUT THIRTY MINUTES TO AN HOUR BEFORE YOU EXERCISE, YOU SHOULD CHECK YOUR CHARTS. CHECK YOUR GLUCOSE CHART TO MAKE SURE YOUR GLUCOSE IS NOT PREDICTED TO DROP IN THE NEAR FUTURE, AND YOUR ACTIVE INSULIN CHART TO SEE HOW MUCH INSULIN IS CURRENTLY WORKING TO LOWER YOUR GLUCOSE." NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, AT THIS TIME.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 03-MAR-2026. ON THEIR FIRST DAY USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM, THE USER EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT FOLLOWING A SHORT WALK. THE USER REPORTED THAT THEIR GLUCOSE SUDDENLY DECREASED TO 38 MG/DL, CHARACTERIZED BY THE INABILITY TO THINK CLEARLY, AS WELL AS PHYSICAL INSTABILITY AND DIAPHORESIS. THE USER REPORTED BEING UNABLE TO TREAT THEMSELVES, AND THE USER'S SPOUSE PROVIDED THEM WITH JELLY BEANS TO RESOLVE THE EVENT. THE USER REPORTED THAT THEY DID NOT INITIATE THE TWIIST WORKOUT PRESET PRIOR TO WALKING. THE USER REMAINED ONGOING ON THE TWIIST AID SYSTEM FOLLOWING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803346 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention| O