BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25262541 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00148
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421431
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT 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 AID SYSTEM. NO ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAS 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 (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED INCREASING GLUCOSE VALUES. UPON INSPECTION, THE USER NOTED THAT THE PIGTAIL TUBING HAD DETACHED FROM THE BODY OF THE TWIIST CASSETTE. THE USER STATED THE CASSETTE HAD BEEN PLACED IN HER BRA AND DENIED ANY PULLING, FORCE, LEAKAGE, OR ALARMS ASSOCIATED WITH THE EVENT. BLOOD GLUCOSE INCREASED TO 358 MG/DL, CONFIRMED BY FINGERSTICK, AND SUBSEQUENTLY, SENSOR GLUCOSE WAS >400. THE USER REPORTED SYMPTOMS OF NAUSEA AND SHORTNESS OF BREATH BUT DENIED REQUIRING EMERGENCY MEDICAL SERVICES. THE USER REPLACED THE CASSETTE AND INFUSION SET TUBING AND WAS ABLE TO DELIVER A BOLUS VIA THE TWIIST PUMP. THE USER ALSO ADMINISTERED INHALED INSULIN (AFREZZA). THE USER REMAINS ONGOING ON THE TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561329 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11073-001 00850017421431

    Patients

    Seq Age Sex Outcome Treatment
    1