BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25222873 · Received May 19, 2026

    Report

    Report Number
    3016798778-2026-00134
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Report Date
    May 19, 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

    THE REPORT THAT THE USER DID NOT REMEMBER ANY ALARMS OCCURRING DURING AN EVENT WHEN THEIR GLUCOSE DECREASED TO 50 MG/DL COULD NOT BE CONFIRMED AS LOG DATA CANNOT BE REVIEWED IN THE ABSENCE OF AN EVENT DATE. ADDITIONALLY, BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE REPORTED HYPOGLYCEMIA IN THE CONTEXT OF AN ONCOMING STOMACH VIRUS COULD NOT BE DETERMINED. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL EVALUATION. THE TWIIST AID SYSTEM USER GUIDE EXPLAINS THAT THE URGENT LOW GLUCOSE ALERT IS DELIVERED AT OR BELOW 55 MG/DL AND WILL PLAY ON THE IPHONE AT THE CRITICAL ALERT VOLUME CONFIGURED WITHIN THE TWIIST APP NOTIFICATION SETTINGS. IF NOT DISMISSED WITHIN 5 MINUTES, THE URGENT LOW GLUCOSE ALERT REPEATS ON THE IPHONE AND WILL PLAY ON THE TWIIST PUMP AT THE PUMP VOLUME LEVEL SET IN THE TWIIST APP NOTIFICATION SETTINGS. IF THE TWIIST APP AND PUMP ARE OUT OF COMMUNICATION, URGENT LOW GLUCOSE SOUNDS WILL PLAY ON THE PUMP IMMEDIATELY. THIS GUIDE ALSO PROVIDES INFORMATION ABOUT THE POTENTIAL CAUSES OF HYPOGLYCEMIA AND HOW TO PREVENT IT.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 19-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY.THE USER REPORTED A PRIOR EVENT THAT OCCURRED ON AN UNKNOWN DATE WHEN THEIR GLUCOSE DECREASED TO 50 MG/DL DUE TO AN ONCOMING STOMACH VIRUS. THE USER STATED THAT THEY DID NOT REMEMBER ANY ALARMS OCCURRING, REPORTING THAT THEIR PHONE WAS WITHIN RANGE BUT NOT CONNECTED VIA BLUETOOTH AT THE TIME OF THE EVENT. THE USER SELF-TREATED WITH GLUCOSE TABLETS AND JUICE TO SUCCESSFULLY RESOLVE THE REPORTED HYPOGLYCEMIA.THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191577 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1