BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23982187 · Received January 6, 2026

    Report

    Report Number
    3016798778-2026-00002
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 7, 2025
    Report Date
    January 6, 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 CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT. SYSTEM LOGS FROM THE TIME OF THE EVENT SHOW THAT THE BASAL INSULIN DELIVERY RATE ADJUSTED AS EXPECTED TO READINGS FROM THE USER'S CONTINUOUS GLUCOSE MONITOR (CGM). THE BASAL RATE DECREASED TO 0 UNITS/HOUR WHEN THE USER'S FORECASTED GLUCOSE WAS PREDICTED TO BE BELOW THE SUSPEND THRESHOLD, AND INCREASED ABOVE THE BASAL RATE WHEN THE USER'S GLUCOSE WAS FORECASTED TO BE HIGHER THAN THE USER'S TARGET GLUCOSE RANGE. ADDITIONALLY, THE DELIVERED VOLUMES OF INSULIN MATCHED THE OWED VOLUMES THROUGHOUT THE TIMEFRAME OF THE COMPLAINT. LEADING UP TO THE REPORTED EVENT, THE SYSTEM LOGS SHOW TRANSIENT OCCLUSION-LIKE BEHAVIOR THAT APPEARED TO BE CONSISTENT WITH AN OCCLUSION EXTERNAL TO THE TWIIST PUMP. THEREFORE, IT WAS DETERMINED THAT THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM WAS OPERATING AS EXPECTED. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AS NO MATERIAL RELEVANT TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 08-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED CHANGING THEIR INFUSION SET ON (B)(6) 2025. ON THE MORNING OF (B)(6) 2025, THE USER EXPERIENCED A SEVERE HEADACHE. THE USER ADMINISTERED BOLUSES OF INSULIN VIA THE TWIIST PUMP BUT REPORTED A GLUCOSE VALUE OF 485 MG/DL. A KETONE TEST PERFORMED BY THE USER WAS REPORTED AS "LARGE." THE USER SUBSEQUENTLY ADMINISTERED INSULIN VIA AN ALTERNATIVE METHOD AND WENT TO THE EMERGENCY ROOM (ER). THE USER WAS ADMINISTERED SALINE AND LEFT THE ER THAT SAME DAY WITH A GLUCOSE VALUE OF 126 MG/DL AND "SMALL" KETONES. THE USER DISCONTINUED USE OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM AS A RESULT OF THE REPORTED EVENT. THE USER REPORTED THAT UPON REMOVAL OF THE INFUSION SITE, THE CANNULA WAS UNREMARKABLE. THE USER RETAINED THE CASSETTE BUT DISPOSED OF THE INFUSION SET TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42822 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other