BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24515770 · Received March 5, 2026

    Report

    Report Number
    3016798778-2026-00043
    Event Type
    Injury
    Date Received
    March 5, 2026
    Report Date
    March 18, 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

    THE USER REPORTED HAVING A HISTORY OF SEVERE HYPOGLYCEMIC EVENTS; HOWEVER THE EXACT DATES OF THESE EVENTS WERE NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) IS NOT PROVIDED IN THIS REPORT. DEVICE FUNCTIONALITY AT THE TIME OF THE HYPOGLYCEMIC EVENTS CANNOT BE ASSESSED THROUGH LOG DATA AS THE EVENT DATES ARE UNKNOWN. ADDITIONALLY, THE DEVICE HAS NOT BEEN RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR EVALUATION. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM AND THE REPORTED HYPOGLYCEMIA COULD NOT BE DETERMINED. EFFORTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING. ANY NEW, RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT, AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO MDR #3016798778-2026-00043, SUBMITTED ON 04-MAR-2026. THIS SUBMISSION INCLUDES ADDITIONAL INFORMATION PROVIDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FROM SEQUEL MED TECH, LLC ON 06-MAR-2026, CONFIRMING THAT THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM WAS NOT IN USE DURING THE REPORTED EVENT. THE USER REPORTED THAT THEIR HISTORY OF SEVERE HYPOGLYCEMIC EVENTS AS DESCRIBED IN THE ORIGINAL MDR SUBMISSION OCCURRED PRIOR TO USING THE TWIIST AID SYSTEM.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY (B)(6), ON 02-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 03-FEB-2026. THE USER REPORTED THAT THEY WERE DISCONTINUING USE OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM DUE TO A HISTORY OF SEVERE HYPOGLYCEMIC EVENTS AND TRAVELING FOR WORK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376553 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Other