BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25237301 · Received May 20, 2026

    Report

    Report Number
    3016798778-2026-00138
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 20, 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

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A SPECIFIC ROOT CAUSE FOR THE REPORTED LINE BLOCKED ALARMS CANNOT BE CONFIRMED. THE LINE BLOCKED ALARM IS IN PLACE TO ALERT THE USER THAT INSULIN IS BLOCKED FROM BEING DELIVERED, WHICH MAY OCCUR DUE TO A KINK IN THE INFUSION SET TUBING OR AT THE INFUSION SITE. OUTREACH ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION WITHOUT RESPONSE. INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE LINE BLOCKED ALARM, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED 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 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 20-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT THEY RECEIVED PERSISTENT LINE BLOCKED ALARMS, DESPITE CHANGING THEIR INFUSION SITE MULTIPLE TIMES. THE USER WAS REPORTEDLY HOSPTIALIZED DUE TO HYPERGLYCEMIA, WITH A CONTINUOUS GLUCOSE MONITOR (CGM) READING OF "HIGH" (>400 MG/DL). THE USER WAS DISCHARGED WITH MANUAL INSULIN INJECTIONS. NO INFORMATION WAS PROVIDED REGARDING THE HOSPITALIZATION OR TREATMENT PROVIDED WHILE ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314508 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