BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25325742 · Received May 28, 2026

    Report

    Report Number
    3016798778-2026-00157
    Event Type
    Injury
    Date Received
    May 28, 2026
    Report Date
    May 28, 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

    THE USER REPORTED EXPERIENCING A HYPOGLYCEMIC EVENT; HOWEVER THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) IS NOT PROVIDED IN THIS REPORT. 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. DEVICE FUNCTIONALITY AT THE TIME OF THE HYPOGLYCEMIC EVENT CANNOT BE ASSESSED THROUGH LOG DATA AS THE EVENT DATE IS UNKNOWN; HOWEVER, THE USER BELIEVED THAT THE EVENT WAS DUE TO PHYSICAL ACTIVITY AND RECENT MEDICATION CHANGES. THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT THE POTENTIAL CAUSES OF HYPOGLYCEMIA AND HOW TO PREVENT IT. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO PRODUCT HAS BEEN RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR EVALUATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-APR-2026. THE USER REPORTED THAT THEY EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE USER REPORTED THAT AFTER ENGAGING IN INTERCOURSE WITH THEIR SPOUSE, THEIR GLUCOSE DECREASED TO 35 MG/DL. THE USER BECAME CONFUSED, HUNGRY AND EXPERIENCED HEART PALPITATIONS. THE USER'S SPOUSE GAVE THEM GINGER ALE, CRACKERS, AND CANDY TO RESOLVE THE LOW GLUCOSE. THE USER FURTHER REPORTED THAT AT THE TIME OF THE EVENT, THEY HAD STARTED A GLP-1 MEDICATION AND THEIR THERAPY SETTINGS HAD NOT BEEN ADJUSTED ACCORDINGLY. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454984 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1