BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25027704 · Received April 29, 2026

    Report

    Report Number
    3016798778-2026-00107
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 29, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE USER REPORTED THAT THEIR HYPOGLYCEMIA WAS RELATED TO BOLUSING TWICE, INVESTIGATION INTO THE REPORTED EVENT IS CURRENTLY 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 POTENTIAL CAUSES OF HYPOGLYCEMIA. ICU MEDICAL'S 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 MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-MAR-2026. THE USER REPORTED THAT ON (B)(6) 2026, THEIR INFUSION SITE WAS RIPPED OUT AFTER THEY HAD INITIATED AN INSULIN BOLUS VIA THE TWIIST PUMP FOR DINNER. THE USER REPLACED THE SITE, RE-ENTERED ANOTHER BOLUS, AND SUBSEQUENTLY EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT WITH A BLOOD GLUCOSE VALUE OF 43 MG/DL. THE USER REPORTED SYMPTOMS INCLUDING LIGHTHEADEDNESS, FATIGUE, WEAKNESS, DIFFICULTY WALKING, AND DIZZINESS. THE USER DID NOT REQUIRE EMERGENCY MEDICAL SERVICES; HOWEVER, THEY WERE UNABLE TO SELF-TREAT AND WERE GIVEN JUICE AND FOOD BY THEIR SPOUSE TO RESOLVE THE LOW BLOOD GLUCOSE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333039 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention| O