BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24769695 · Received April 2, 2026

    Report

    Report Number
    3016798778-2026-00081
    Event Type
    Injury
    Date Received
    April 2, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    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 A HYPOGLYCEMIC EVENT; HOWEVER THE EXACT DATE OF THIS EVENT WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) IS NOT PROVIDED IN THIS REPORT. DEVICE FUNCTIONALITY AT THE TIME OF THE HYPOGLYCEMIC EVENT CANNOT BE ASSESSED THROUGH LOG DATA AS THE EVENT DATE IS UNKNOWN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO PRODUCT HAS BEEN RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR EVALUATION. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A DEVICE MALFUNCTION COULD NOT BE IDENTIFIED AND A CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE REPORTED HYPOGLYCEMIA CANNOT BE DETERMINED. THE CURRENT VERSION OF THE TWIIST 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."

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 05-MAR-2026. THE USER REPORTED HAVING A SEVERE HYPOGLYCEMIC EVENT RELATED TO EXERCISE WHILE USING TWIIST'S WORKOUT PRESET. THE USER REPORTED THAT THEIR BLOOD GLUCOSE QUICKLY DECREASED AFTER EATING DINNER. THE USER'S SPOUSE HAD TO PROVIDE THE USER WITH ORANGE JUICE AS THEY HAD A BLANK STARE AND WERE REPORTEDLY "FADING FAST." THE USER REPORTED A BLOOD GLUCOSE VALUE OF 39 MG/DL, BUT LATER STATED THAT IT ONLY WENT AS LOW AS 54 MG/DL.THE USER MENTIONED THINKING THAT THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM WAS NOT WORKING AS EXPECTED BUT NO PUMP-RELATED ALARMS WERE REPORTED. THE USER WAS EDUCATED ON CHECKING THEIR BLOOD GLUCOSE PRIOR TO INITIATING THE WORKOUT PRESET. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832400 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Other