BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23882810 · Received December 23, 2025

    Report

    Report Number
    3016798778-2025-00149
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 26, 2025
    Report Date
    December 23, 2025
    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

    REVIEW OF THE INITIAL REPORTED EVENT RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON (B)(6) 2025 INDICATED THAT THE USER CHANGED THEIR INFUSION SITE TO ADDRESS ELEVATED BLOOD GLUCOSE LEVELS ON (B)(6) 2025. ASSESSMENT OF THE PROVIDED EVENT DETAILS FURTHER INDICATED THAT NO ACTIONS WERE TAKEN WITH THE TWIIST PUMP, CASSETTE, OR APP BETWEEN THE PERIOD OF ELEVATED GLUCOSE AND THE SUBSEQUENT HYPOGLYCEMIC EVENT AND DIABETIC SEIZURE. THE INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR USE WITH THE TWIIST AID SYSTEM. LOG FILES FROM THE DATE OF THE REPORTED EVENT ARE NOT AVAILABLE FOR REVIEW. THE AVAILABLE LOGS CONTAIN DATA FROM (B)(6) 2025 UTC AND CAPTURE THE BASAL RATE BEING ADJUSTED AS EXPECTED TO THE READINGS FROM ABBOTT'S FREESTYLE LIBRE 3+ SENSOR; SHOW BOLUSES BEING PERFORMED SUCCESSFULLY AND LOWERING THE USER'S GLUCOSE AS INTENDED; AND VERIFY THE DELIVERED INSULIN VOLUMES MATCHING THE OWED INSULIN VOLUMES. REVIEW OF THE LOG DATA FOLLOWING THE DATE OF THE REPORTED EVENT SHOWS THE TWIIST AID SYSTEM FUNCTIONING AS INTENDED THROUGHOUT THE TIMEFRAME AVAILABLE FOR ASSESSMENT. HOWEVER, BECAUSE NO LOG DATA FROM THE DATE OF THE REPORTED EVENT IS AVAILABLE AND NO PRODUCT WAS RETURNED FOR EVALUATION, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AS DEVICE PERFORMANCE AT THE TIME OF THE EVENT COULD NOT BE ASSESSED. THE DATE RECEIVED BY MANUFACTURER (G3) IS DOCUMENTED AS 12-DEC-2025, WHICH CORRESPONDS TO THE CLOSE OF MILLYARD ADVANCED MEDICAL PRODUCTS, LLC'S LOG INVESTIGATION. SIMILARLY, THE REPORT SOURCE (G2) IS DOCUMENTED AS A COMPANY REPRESENTATIVE. NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC. THE USER REMAINS ONGOING ON TWIIST PUMP (B)(6).

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 03-NOV-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED WEARING AN INFUSION SITE ON THEIR ABDOMEN AND HAVING ELEVATED GLUCOSE VALUES ABOVE 250MG/DL THROUGHOUT THE DAY. THE USER REPORTED CHANGING THEIR INFUSION SITE, WHICH SUBSEQUENTLY CAUSED THEIR GLUCOSE TO DECREASE TO 40 MG/DL, RESULTING IN A DIABETIC SEIZURE. EMERGENCY MEDICAL SERVICES WERE CALLED AND SUCCESSFULLY HELPED BRING THE USER'S GLUCOSE BACK UP TO A NORMAL RANGE. SEQUEL PROVIDED ADDITIONAL TRAINING ON ABSORPTION, SCAR TISSUE, AND ROTATING INFUSION SITES AS THE USER REPORTED THAT THEY HAVE BEEN ON AN INFUSION PUMP FOR A LONG TIME. THE USER REMAINS ONGOING ON TWIIST PUMP, SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919040 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other| R