BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24443081 · Received February 25, 2026

    Report

    Report Number
    3016798778-2026-00039
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 13, 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

    FOLLOW-UP TO MDR #3016798778-2026-00039, SUBMITTED ON 25-FEB-2026. THIS SUBMISSION PROVIDES CORRECTIONS TO PREVIOUSLY REPORTED INFORMATION AND INCLUDES INFORMATION OBTAINED ON 27-FEB-2026 THROUGH AN INVESTIGATION OF LOG DATA. ALTHOUGH A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, LOG DATA INDICATES THAT THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM FUNCTION AS INTENDED. REVIEW OF LOG DATA CONFIRMED THAT AN URGENT LOW GLUCOSE ALERT WAS GENERATED ON (B)(6) 2026 WHILE THE TWIIST APP WAS IN THE BACKGROUND OF THE USER'S IPHONE, OVERRIDING A LOW GLUCOSE ALERT TRIGGERED FOUR MINUTES PRIOR. THE URGENT LOW GLUCOSE ALERT WAS ISSUED TO THE IPHONE'S OPERATING SYSTEM (IOS), AND THE LOW GLUCOSE ALERT WAS RETRACTED. TWENTY-EIGHT MINUTES LATER, THE URGENT LOW GLUCOSE ALERT WAS RETRACTED BECAUSE THE USER'S GLUCOSE INCREASED ABOVE THE THRESHOLD OF THE URGENT LOW GLUCOSE ALERT, PER DESIGN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN 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. SECTION H1 AND THE CODES IN SECTION H6 WERE UPDATED TO ALIGN WITH THE INVESTIGATION RESULTS. CORRECTIONS WERE MADE TO SECTIONS H4 AND H8.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE REPORTED ISSUE REMAINS ONGOING. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN 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.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 20-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. REPORTABLE INFORMATION ASSOCIATED WITH THE EVENT WAS SUBSEQUENTLY RECEIVED BY SEQUEL MED TECH, LLC, ON 02-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 18-FEB-2026. ON (B)(6) 2026, THE USER REPORTED THAT THEIR BLOOD GLUCOSE DECREASED TO 53 MG/DL AND THEIR IPHONE NEVER ALERTED THEM. THE USER CONFIRMED THAT THE ALERTS WERE VISIBLE IN THE EVENT HISTORY OF THE TWIIST APP. ON (B)(6) 2026, THE USER EXPLAINED THAT THEY WERE SYMPTOMATIC DURING THE LOW GLUCOSE EVENT ON (B)(6) 2026, STATING THAT THEY WERE SHAKY AND SWEATY. THE USER CONSUMED CARBOHYDRATES TO RESOLVE THEIR LOW GLUCOSE. THE USER ALSO CLARIFIED THAT THEIR CONTINUOUS GLUCOSE MONITOR WAS NOT BEING COMPRESSED AT THE TIME OF THE EVENT. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292446 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Other