BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24690422 · Received March 25, 2026

    Report

    Report Number
    3016798778-2026-00064
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 20, 2026
    Report Date
    March 25, 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

    A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. NO MATERIAL WAS RETURNED FOR INVESTIGATION AND LOG DATA IS NOT AVAILABLE FOR REVIEW. THE USER REPORTED CHANGING SOME OF THEIR THERAPY SETTINGS TO ADDRESS THEIR INITIAL BLOOD GLUCOSE ELEVATION AND THAT THE PROLONGATION OF THEIR HYPERGLYCEMIA OCCURRED IN THE CONTEXT OF A BENT INFUSION SET CANNULA. ICU MEDICAL'S CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 25-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED A SENSOR GLUCOSE VALUE OF OVER 400 MG/DL AND HIGH KETONES ON (B)(6) 2026. THE USER CHANGED THEIR TWIIST CASSETTE AND CLEO 90 INFUSION SET AFTER ADJUSTING SOME OF THEIR THERAPY SETTINGS. THE USER REPORTED THAT THEIR GLUCOSE DECREASED A LITTLE BUT ULTIMATELY INCREASED AGAIN. THE USER THEN REMOVED THE CLEO 90 INFUSION SITE AND OBSERVED THAT THE CANNULA WAS BENT. THE USER REPORTED THAT THEIR GLUCOSE SUBSEQUENTLY DECREASED AS EXPECTED. THE USER CONFIRMED THAT THEY DID NOT SEEK MEDICAL ASSISTANCE DURING THE REPORTED EVENT. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403992 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 46 YR Female Other