BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25061918 · Received May 1, 2026

    Report

    Report Number
    3016798778-2026-00116
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 1, 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. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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 CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 03-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. ON THE EVENING OF (B)(6) 2026 THROUGH THE MORNING OF (B)(6) 2026, THE USER EXPERIENCED SUSTAINED HYPERGLYCEMIA (>400 MG/DL) ACCOMPANIED BY NAUSEA AND VOMITING. AT APPROXIMATELY 10:00 AM ON (B)(6) 2026, THEY CHANGED THEIR TWIIST CASSETTE AND CLEO 90 INFUSION SET AND INSERTED A NEW INFUSION SITE ON THEIR ABDOMEN. FOLLOWING A MANUAL INSULIN INJECTION, BLOOD GLUCOSE DECREASED TO APPROXIMATELY 350 MG/DL, CONFIRMED BY A FINGERSTICK; HOWEVER, THE USER VOMITED AGAIN AND THEY PRESENTED TO THE EMERGENCY DEPARTMENT (ED) AFTER ADMINISTERING AN ADDITIONAL INJECTION. IN THE ED, INTRAVENOUS SALINE WAS ADMINISTERED AND THE TWIIST PUMP WAS RESUMED. DURING THE APPROXIMATE 4-HOUR ED VISIT, GLUCOSE LEVELS DECREASED INTO THE 100S MG/DL AND SUBSEQUENTLY REMAINED STABLE. THE USER REPORTED NO PUMP-RELATED ALARMS PRIOR TO THE HYPERGLYCEMIC EVENT AND DENIED CHANGES IN DIET, MEDICATIONS, ACTIVITY LEVEL, OR INTERCURRENT ILLNESS. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81212 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 Other