BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24719501 · Received March 30, 2026

    Report

    Report Number
    3016798778-2026-00071
    Event Type
    Injury
    Date Received
    March 30, 2026
    Report Date
    March 27, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, INITIALLY ASSESSED THIS EVENT AS NON-REPORTABLE BASED ON SUPPLEMENTAL INFORMATION INDICATING THAT THE USER DID NOT EXPERIENCE SERIOUS CLINICAL SYMPTOMS AND THAT THE HYPOGLYCEMIA WAS RESOLVED BY DRINKING ORANGE JUICE. HOWEVER, UPON FURTHER INVESTIGATION AND RECEIPT OF CLARIFIED CLINICAL DETAILS REPORTED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON (B)(6) 2026 BY SEQUEL MED TECH, LLC, IT WAS DETERMINED THAT THE SUPPLEMENTAL INFORMATION PERTAINED TO A DISTINCT, UNRELATED EVENT. CONSEQUENTLY, DUE TO THE INABILITY TO CONFIRM THE CLINICAL OUTCOME OF THE HYPOGLYCEMIC EVENT THAT WAS REPORTED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON (B)(6) 2026, THE EVENT WAS UPGRADED TO REPORTABLE STATUS. SECTION G2 REFLECTS THAT THE SUPPLEMENTAL INFORMATION PROVIDED BY SEQUEL MED TECH, LLC, ON (B)(6) 2026 MADE THE INITIAL EVENT REPORTABLE. A SPECIFIC ROOT CAUSE FOR THE REPORTED HYPOGLYCEMIA COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. THE EXACT DATE OF THE REPORTED HYPOGLYCEMIA WAS NOT PROVIDED; THEREFORE, DEVICE LOG ANALYSIS FOR THE EVENT PERIOD CANNOT BE PERFORMED. THE USER CONTINUES TO USE THE TWIIST PUMP, AND NO COMPONENTS HAVE BEEN RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR EVALUATION. BASED ON THE CURRENT LACK OF CLINICAL DETAILS AND THE INABILITY TO CORRELATE THE EVENT WITH SPECIFIC DEVICE DATA, A RELATIONSHIP BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM AND THE REPORTED HYPOGLYCEMIA COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECIEVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON (B)(6) 2026 INDICATING THAT THE USER EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT ON AN UNKNOWN DATE. ADDITIONAL INFORMATION WAS LATER RECEIVED BY SEQUEL MED TECH, LLC, ON (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, THAT SAME DAY INDICATING THAT THE USER DID NOT EXPERIENCE SERIOUS CLINICAL SYMPTOMS AND THE HYPOGLYCEMIC EVENT WAS RESOLVED BY DRINKING ORANGE JUICE. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783448 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other