BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25061916 · Received May 1, 2026

    Report

    Report Number
    3016798778-2026-00113
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 1, 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

    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 USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE, PROVIDES INFORMATION ABOUT POTENTIAL CAUSES OF HYPOGLYCEMIA. THIS GUIDE EXPLAINS THAT, IF LOOP IS ON AND CONTINOUS GLUCOSE MONITOR (CGM) SIGNAL LOSS OCCURS, THE TWIIST AID SYSTEM WILL NOT BE ABLE TO COMPLETE A LOOP IN ORDER TO ADJUST BASAL DELIVERY. ABBOTT DIABETES CARE'S FREESTYLE LIBRE 3 PLUS IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWISIT AUTOMATED INSULIN DELIVERY SYSTEM. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 01-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED EXPERIENCING LOW GLUCOSE VALUES OVERNIGHT AND AWOKE WITH A GLUCOSE READING IN THE 70 MG/DL RANGE. AFTER WAKING, THE USER CONSUMED BREAKFAST AND ENTERED 35 GRAMS OF CARBOHYDRATES INTO THE TWIIST APP; NO BOLUS WAS RECOMMENDED BY THE SYSTEM. THE USER'S GLUCOSE INCREASED SLIGHTLY AND SUBSEQUENTLY DECREASED INTO THE 60 MG/DL RANGE. THE USER TREATED THE HYPOGLYCEMIA WITH CANDY. LATER, THE USER ADMINISTERED A BOLUS FOR LUNCH, AFTER WHICH THEIR GLUCOSE LEVEL DECREASED TO 54 MG/DL. THE USER REPORTED ASSOCIATED SYMPTOMS OF SHAKINESS AND BLURRED VISION. NO EMERGENCY MEDICAL SERVICES WERE REQUIRED, AND THE USER SELF-TREATED AT HOME. THE USER ALSO REPORTED THAT, ON THE NIGHT PRIOR TO THE EVENT, THERE WERE CONTINUOUS GLUCOSE MONITOR (CGM) SIGNAL LOSS ALERTS. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431185 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other