BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24307821 · Received February 10, 2026

    Report

    Report Number
    3016798778-2026-00021
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 26, 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 CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S SYMPTOMS COULD NOT BE CONFIRMED. ALTHOUGH INVESTIGATION IS ONGOING, THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION BECAUSE THE TWIIST AID SYSTEM'S ABILITY TO CALCULATE THE APPROPRIATE AMOUNT OF INSULIN TO DELIVER TO A USER IS DETERMINED BY INPUT FROM THEIR CONTINUOUS GLUCOSE MONITOR (CGM). IT WAS REPORTED BY THE USER THAT THEIR CGM WAS READING LOWER THAN THEIR FINGERSTICK BLOOD GLUCOSE VALUE, WHICH WOULD HAVE IMPACTED THE TWIIST AID SYSTEM'S DOSING OF INSULIN TO THE USER AND BOLUS RECOMMENDATIONS. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S SYMPTOMS COULD NOT BE CONFIRMED. DUE TO THE LACK OF RETURNED PRODUCT AND ELECTRONIC LOG DATA, SYSTEM PERFORMANCE COULD NOT BE VERIFIED. THE APPLICABLE CODES WERE MODIFIED IN SECTION H6. THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION BECAUSE IT WAS REPORTED THAT THE ABBOTT FREESTYLE LIBRE 3 PLUS CONTINOUS GLUCOSE MONITOR (CGM) WAS READING OVER 100 MG/DL LOWER THAN THE USER'S FINGERSTICK BLOOD GLUCOSE VALUE, WHICH WOULD HAVE IMPACTED THE TWIIST AID SYSTEM'S DOSING AND BOLUS RECOMMENDATIONS. IT WAS ALSO REPORTED THAT BLOOD MIXED WITH INSULIN POURED OUT OF THE CLEO 90 INFUSION SITE UPON REMOVAL, INDICATING THAT INSULIN WAS BEING DELIVERED VIA THE TWIIST PUMP. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. ICU MEDICAL'S 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. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE EXPLAINS THAT IF CGM READINGS DO NOT MATCH SYMPTOMS OR A FINGERSTICK READING FROM A BLOOD GLUCOSE METER, THE CGM MAY BE HAVING A PROBLEM. INSTRUCTIONS FOR HOW TO ENTER A FINGERSTICK VALUE ARE ALSO INCLUDED IN THIS GUIDE, AS WELL AS INFORMATION ABOUT HOW THE SYSTEM RECOMMENDS A BOLUS.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 11-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED AN ISSUE WITH THEIR INFUSION SITE ON (B)(6) 2026 THAT LED TO DIABETIC KETOACIDOSIS. THE USER REPORTED CHANGING THEIR CLEO 90 INFUSION SITE AND TUBING, AS WELL AS THEIR TWIIST CASSETTE PRIOR TO GOING TO SLEEP. THROUGHOUT THE NIGHT, THE USER REPORTED THAT THEIR GLUCOSE VALUES INCREASED AND THAT THE TWIIST APP DID NOT SUGGEST A BOLUS. ACCORDING TO THE USER, THEIR ABBOTT FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITOR VALUES DID NOT EXCEED 270 MG/DL DURING THIS TIME; HOWEVER, A FINGERSTICK REVEALED A GLUCOSE VALUE OF 389 MG/DL. UPON REMOVING THE INFUSION SITE LOCATED ON THE LEFT SIDE OF THEIR ABDOMEN, APPROXIMATELY ONE TEASPOON OF BLOOD MIXED WITH INSULIN POURED OUT. THE USER REPORTED TESTING POSITIVE FOR LARGE KETONES AND THEY ADMINISTERED FIVE UNITS OF INSULIN VIA AN INJECTION. THE USER ALSO REPORTED THAT THEY DRANK WATER WITH ELECTROLYTES TO REDUCE THEIR GLUCOSE LEVELS, AND EMERGENCY SERVICES WERE NOT REQUIRED. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368972 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other