BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25191694 · Received May 15, 2026

    Report

    Report Number
    3016798778-2026-00131
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. THE INVESTIGATION INTO THE REPORTED EVENT IS CURRENTLY ONGOING. A FOLLOW-UP REPORT CONTAINING THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON ITS COMPLETION. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE CGM HIGH GLUCOSE ALERT, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE 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 MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-APR-2026. THE USER REPORTED THAT THEY HAD ISSUES WITH THEIR TWIIST CASSETTE AND "AIGE" AROUND (B)(6) 2026, AND THEIR BLOOD GLUCOSE VALUES INCREASED ABOVE 400 MG/DL. THE USER EXPERIENCED DIABETIC KETOACIDOSIS AND GAVE THEMSELVES A MANUAL INJECTION OF 15 UNITS OF INSULIN. THE USER FURTHER REPORTED THAT THEY FULLY RECOVERED FROM THE EVENT. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429705 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