BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23845864 · Received December 18, 2025

    Report

    Report Number
    3016798778-2025-00145
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    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 USER STARTED THERAPY ON THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM ON 14-NOV-2025. IT IS UNKNOWN IF THE REPORTED LEAKING FROM THE "TUBING ATTACHED TO THE CASSETTE" REFERS TO THE PIGTAIL ATTACHED TO THE CASSETTE, OR THE INFUSION SET THAT ATTACHES TO THE LUER AT THE END OF THE CASSETTE'S PIGTAIL. THE INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. A SPECIFIC CAUSE FOR THE ELEVATED GLUCOSE VALUES REPORTED BY THE USER COULD NOT BE CONFIRMED AS NO LOG FILES ARE AVAILABLE FOR ANALYSIS. ADDITIONALLY, A POTENTIAL CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM AND THE USER'S UNSPECIFIED INFECTION COULD NOT BE ASSESSED BASED ON THE INFORMATION PROVIDED. FURTHERMORE, A POTENTIAL CORRELATION BETWEEN THE USE OF THE CASSETTE BEYOND THE 72 HOURS (3 DAYS) MAXIMUM USE TIME STATED IN THE TWIIST AID SYSTEM USER GUIDE AND THE REPORTED EVENT COULD NOT BE ASSESSED AS NO PRODUCT WAS RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCT, LLC, FOR INVESTIGATION, AND NO SERIAL OR LOT INFORMATION WAS PROVIDED FOR THE CASSETTE. NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 19-NOV-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED HAVING HIGHER THAN USUAL GLUCOSE VALUES, 270-280 MG/DL, ON 15-NOV-2025 AND 16-NOV-2025. ON 17-NOV-2025, THE USER REPORTED THAT THEY CHANGED THEIR INFUSION SITE, WHICH REPORTEDLY CAUSED THEIR GLUCOSE VALUES TO DECREASE. THE USER WAS ALSO DUE TO EXCHANGE THEIR CASSETTE AT THAT TIME, PER THE INSTRUCTIONS IN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE, BUT ELECTED NOT TO AS THERE WAS INSULIN REMAINING. DESPITE HAVING GLUCOSE VALUES OF 120-170 MG/DL ON 18-NOV-2025, THE USER REPORTED EXPERIENCING CHEST PAIN, BACK PAIN, ELEVATED BLOOD PRESSURE, ELEVATED WHITE BLOOD CELL COUNT, AND VOMITING. THE USER ALSO REPORTED THAT THE TWIIST PUMP FELT WET AND THAT THE TUBING ATTACHED TO THE CASSETTE WAS LEAKING. THE USER REPORTED BEING HOSPITALIZED FROM 18-NOV-2025 TO 20-NOV-2025 DUE TO DIABETIC KETOACIDOSIS AND AN INFECTION, AND REPORTED RECEIVING TREATMENT WITH ANTIBIOTICS AND INTRAVENOUS FLUIDS. THE USER REPORTED DISCONTINUING USE OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM. THE USER ALSO REPORTED THAT THE CASSETTE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238434 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007; DKPI-11099-001 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Hospitalization