BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24406307 · Received February 20, 2026

    Report

    Report Number
    3016798778-2026-00035
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 25, 2026
    Report Date
    February 25, 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 REPORTED EVENT COULD NOT BE CONFIRMED. IT IS UNKNOWN IF THE USER WAS ADMITTED TO THE HOSPITAL. NO PRODUCT WAS RETURNED FOR INVESTIGATION AND LOG DATA IS NOT AVAILABLE FOR REVIEW. 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

    INFORMATION REGARDING THE PATIENT'S ADMISSION TO THE HOSPITAL HAS BEEN INCORPORATED INTO THE EVENT NARRATIVE (B5). SECTIONS B2 AND H6 WERE ALSO UPDATED TO REFLECT THE PATIENT'S HOSPITALIZATION.

    Additional Manufacturer Narrative · 0

    SECTION H6 WAS UPDATED TO REFLECT THAT DIABETIC KETOACIDOSIS IS A KNOWN INHERENT RISK OF THE DEVICE AND THAT NO INVESTIGATION FINDINGS ARE AVAILABLE AS NO PRODUCT WAS RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR EVALUATION AND NO LOG DATA IS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 26-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT THEY HAD DIABETIC KETOACIDOSIS AND WENT TO THE HOSPITAL. THE USER DISCONTINUED USE OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 26-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT THEY HAD DIABETIC KETOACIDOSIS AND WERE ADMITTED TO THE HOSPITAL. THE USER DISCONTINUED USE OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468141 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| O