BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25339400 · Received May 29, 2026

    Report

    Report Number
    3016798778-2026-00167
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 29, 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

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE PATIENT'S DIABETIC KETOACIDOSIS (DKA) CANNOT BE CONFIRMED. INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. OUTREACH ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION WITHOUT RESPONSE. THE CURRENT VERSION OF THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE INSTRUCTS USERS 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 TWIST 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 01-MAY-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-MAY-2026. THE USER REPORTED THAT MULTIPLE TIMES A WEEK, THEY FELT THAT THEIR INSULIN WAS NOT BEING ABSORBED; HOWEVER, THE USER DENIED RECEIVING ANY ALARMS FROM THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND STATED THAT UPON REMOVAL OF THEIR INFUSION SITE, THE CANNULA WAS NOT KINKED. THE USER ALSO REPORTED THAT ON (B)(6) 2026, THEY DID NOT "GET INSULIN DURING THE NIGHT" AND WAS IN DIABETIC KETOACIDOSIS (DKA) THE FOLLOWING MORNING. THE USER CONTACTED THEIR HEALTH CARE PROVIDER AND THEIR DKA ULTIMATELY RESOLVED. THE USER FURTHER REPORTED THAT THEY HAD SMALL AMOUNTS OF KETONES. THE USER REMAINS ONGOING ON THEIR TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592129 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1