BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24795618 · Received April 6, 2026

    Report

    Report Number
    3016798778-2026-00084
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 7, 2026
    Report Date
    April 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

    BASED ON THE INFORMATION AVAILABLE, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT AND A RELATIONSHIP BETWEEN THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S REPORTED SYMPTOMS CANNOT BE DETERMINED. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM. THE CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT POTENTIAL CAUSES OF HYPERGLYCEMIA. THIS USER GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, AT THIS TIME.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 07-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED THAT AFTER INITIATING THERAPY VIA THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM ON (B)(6) 2026, THEIR BLOOD GLUCOSE WAS ELEVATED OVERNIGHT. THE FOLLOWING MORNING, THE USER EXCHANGED THEIR INFUSION SET; HOWEVER, THEIR BLOOD GLUCOSE REMAINED IN THE 300S (MG/DL). THE USER LATER REPORTED THAT THEY FOUND THEMSELVES IN DIABETIC KETOACIDOSIS AND ULTIMATELY EXCHANGED THEIR TWIIST CASSETTE, FOLLOWING WHICH, THEIR GLUCOSE VALUES BEGAN TO DECREASE. THE USER DENIED RECEIVING ANY PUMP ALARMS AND REPORTED HAVING NO FURTHER ISSUES WITH THE SYSTEM. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76242 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007; DKPI-11073-001 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other