BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24515330 · Received March 5, 2026

    Report

    Report Number
    3016798778-2026-00044
    Event Type
    Injury
    Date Received
    March 5, 2026
    Report Date
    March 17, 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

    THE USER REPORTED HAVING A SEVERE HYPOGLYCEMIC EVENT; HOWEVER THE EXACT DATE OF THIS EVENT WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) IS NOT PROVIDED IN THIS REPORT. DEVICE FUNCTIONALITY AT THE TIME OF THE HYPOGLYCEMIC EVENT CANNOT BE ASSESSED THROUGH LOG DATA AS THE EVENT DATE IS UNKNOWN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO PRODUCT HAS 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 #3016798778-2026-00044, SUBMITTED ON 04-MAR-2026. THIS SUBMISSION INCLUDES ADDITIONAL INFORMATION PROVIDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FROM SEQUEL MED TECH, LLC ON 12-MAR-2026, CONFIRMING THAT THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM WAS NOT IN USE DURING THE REPORTED EVENT. THE USER REPORTED THAT THE SEVERE HYPOGLYCEMIC EVENT DESCRIBED IN THE ORIGINAL MDR SUBMISSION OCCURRED ON ANOTHER MANUFACTURER'S DEVICE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 02-FEB-2026. THE USER REPORTED THAT THEY EXPERIENCED ONE SEVERE HYPOGLYCEMIC EVENT OVERNIGHT SINCE INITIATING THERAPY WITH THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE USER REPORTEDLY HAD A BLOOD GLUCOSE VALUE OF 35 MG/DL DURING THE EVENT AND WAS UNABLE TO BE AWAKENED. EMERGENCY MEDICAL SERVICES WERE CONTACTED AND THE USER REPORTED TREATMENT WITH GLUCAGON; HOWEVER, IT WAS CONFIRMED THAT THE USER WAS NOT TRANSPORTED TO THE EMERGENCY ROOM. THE USER REPORTED THAT THEY DID NOT BELIEVE THE EVENT WAS RELATED TO THE TWIIST PUMP. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443095 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other