BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24916771 · Received April 17, 2026

    Report

    Report Number
    3016798778-2026-00096
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 17, 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

    A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. ALTHOUGH THE USER ATTRIBUTED THEIR GLYCEMIC INSTABILITY TO THEIR THERAPY SETTINGS, HYPOGLYCEMIA AND HYPERGLYCEMIA ARE CAPTURED IN SECTION H6 DUE TO THE REPORT THAT ALERTS ARE SOMETIMES NOT HEARD BY THE USER. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE EXPLAINS THAT AN URGENT LOW GLUCOSE ALERT NOTIFIES THE USER WHEN THEIR SENSOR GLUCOSE READING GOES BELOW 55 MG/DL. THE URGENT LOW GLUCOSE ALERT CANNOT BE DISABLED AND IS ALWAYS PLAYED BY THE IPHONE EVEN WHEN THE IPHONE IS SILENCED OR FOCUS IS ENABLED. THE LOW GLUCOSE ALERT IS ON BY DEFAULT AND IS INITIALLY SET TO 70 MG/DL BUT CAN BE SET BETWEEN 60-100 MG/DL IN 5 MG/DL INCREMENTS. OVERRIDE FOCUS IS TURNED ON BY DEFAULT TO ENABLE THE LOW GLUCOSE ALERT TO ALWAYS PLAY A SOUND AND APPEAR ON THE LOCK SCREEN EVEN IF THE IPHONE IS MUTED OR FOCUS IS ON. THE CGM HIGH GLUCOSE ALERT IS ON BY DEFAULT, AND IS INITIALLY SET TO 250 MG/DL. THE USER GUIDE EXPLAINS THAT ONLY ONE CGM HIGH GLUCOSE ALERT WILL BE TRIGGERED PER HIGH GLUCOSE EPISODE. THIS GUIDE ALSO EXPLAINS THAT A LONGER ABSORPTION TIME SHOULD BE CHOSEN WHEN BOLUSING FOR LARGER MEALS, OR THOSE CONTAINING FATS AND PROTEINS. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 18-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED FIVE EPISODES OF HIGH AND LOW BLOOD GLUCOSE ON 18-MAR-2026 (LOWEST REPORTED VALUE: 48 MG/DL). THE USER NOTED A PRE-EXISTING HEARING IMPAIRMENT AND STATED THAT, WHILE THEY CAN SOMETIMES HEAR HIGH GLUCOSE ALERTS, THEY DO NOT HEAR URGENT LOW GLUCOSE ALERTS. HOWEVER, THE USER REPORTED THAT SOMETIMES FAMILY MEMBERS DO HEAR THE ALERTS BEFORE THEY DO. DURING ONE EPISODE, THE USER DID NOT HEAR THE URGENT LOW GLUCOSE ALERT AND REPORTED SHAKING AND NEAR-SYNCOPE WITH A BLOOD GLUCOSE VALUE OF 50 MG/DL. THE USER SELF-TREATED WITH SODA AND FROSTING. THE USER LATER REPORTED THAT THEY HAD BOLUSED FOR A MEAL OF BEEF AND CARBOHYDRATES USING THE MEDIUM CARBOHYDRATE EFFECT OPTION IN THE TWIST APP PRIOR TO THE HYPOGLYCEMIC EVENTS EXPERIENCED. THE USER ATTRIBUTED THEIR GLYCEMIC INSTABILITY TO RECENT THERAPY SETTING CHANGES MADE BY THEIR HEALTHCARE PROVIDER (HCP), THE DETAILS OF WHICH WERE UNKNOWN TO THE USER. THE USER REMAINS ONGOING ON THE TWIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617136 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other