BEUDAMED
    FDA Adverse Event Death Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24927143 · Received April 20, 2026

    Report

    Report Number
    3016798778-2026-00100
    Event Type
    Death
    Date Received
    April 20, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 20, 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. MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, IS PERFORMING AN EXHAUSTIVE INVESTIGATION TO SECURE ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE FOR FORENSIC ENGINEERING EVALUATION. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 23-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. IT WAS REPORTED THAT THE USER PASSED AWAY ON (B)(6) 2026 FOLLOWING A HYPOGLYCEMIC EVENT WHILE USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. ACCORDING TO THE USER'S FATHER, THEY TYPICALLY USED THE TWIIST AID SYSTEM WITH A CONTINUOUS GLUCOSE MONITOR (CGM); HOWEVER, THE USER WAS NOT WEARING A CGM AT THE TIME OF THE EVENT FOR AN UNKNOWN REASON. THERE WERE NO REPORTS OF DEVICE ALERTS OR ALARMS PRIOR TO THE EVENT. THE USER'S BLOOD GLUCOSE LEVEL AT THE TIME OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990145 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Death