BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25237300 · Received May 20, 2026

    Report

    Report Number
    3016798778-2026-00139
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 18, 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

    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. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE CGM HIGH GLUCOSE ALERT, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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 20-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. ON (B)(6) 2026, THE USER REPORTED THAT THEIR GLUCOSE VALUES HAD BEEN IN THE UPPER 300-400S (MG/DL) RANGE FOR THE PAST THREE DAYS, WITH THE HIGHEST GLUCOSE VALUE REPORTED AS 566 MG/DL. THE USER ALSO REPORTED THAT THEY EXPERIENCED SYMPTOMS OF NAUSEA AND HEART PALPITATIONS, AND TESTED POSITIVE FOR MODERATE KETONES. THE USER TREATED THEIR ELEVATED GLUCOSE WITH MANUAL INSULIN INJECTIONS AND ALSO REPORTED THAT THEIR GLUCOSE VALUES WERE DOWN-TRENDING ON (B)(6) 2026 AFTER TURNING OFF LOOP. THE USER CONFIRMED THAT THEY ROTATE INFUSION SITES AND HAD CHANGED INFUSION SITES THREE TIMES ON (B)(6) 2026. THE USER FURTHER REPORTED THAT THEIR CARBOHYDRATE ENTRIES WERE ROUTINE AND ACCURATE; HOWEVER, THEY OFTEN DID NOT RECEIVE RECOMMENDED BOLUSES FROM THE TWIIST APP FOR THEIR MEALS. ADDITIONALLY, THEY HAD NOT RECEIVED THEIR MAX BASAL RATE OF INSULIN, DESPITE THEIR ELEVATED GLUCOSE VALUES. THE USER STATED THAT THEY ALTERED THEIR THERAPY SETTINGS ON AN UNKNOWN DATE AND WAS ADVISED REVIEWING THEIR SETTINGS WITH THEIR PHYSICIAN OR DIABETES EDUCATOR. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314507 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1