BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25191691 · Received May 15, 2026

    Report

    Report Number
    3016798778-2026-00132
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 15, 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
    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 CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. A REVIEW OF THE USER'S COMPLAINT HISTORY REVEALED NO PRIOR EVENTS REPORTING DIABETIC KETOACIDOSIS. 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 15-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED HAVING DIFFICULTY COMPLETING A CASSETTE CHANGE DUE TO AN ERROR. MULTIPLE PUMP ERRORS, AS WELL AS A CASSETTE ERROR, WERE OBSERVED, AND A PUMP REPLACEMENT WAS RECOMMENDED. THE USER'S MOTHER REPORTED THAT THIS WAS THE SECOND TIME THAT THE USER HAD EXPERIENCED DIABETIC KETOACIDOSIS SINCE INITIATING TWIIST THERAPY. THE USER'S SENSOR GLUCOSE WAS 336 MG/DL AT THE TIME OF THE EVENT, WHICH WAS NOT CONFIRMED BY FINGERSTICK. THE USER REPORTED THEIR INTENT TO REVERT TO AN ALTERNATIVE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274767 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