BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24779312 · Received April 3, 2026

    Report

    Report Number
    3016798778-2026-00082
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 3, 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, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT AND A RELATIONSHIP BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S REPORTED SYMPTOMS CANNOT BE DETERMINED. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM. THE CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT POTENTIAL CAUSES OF HYPERGLYCEMIA. THIS USER GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. 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, AT THIS TIME.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 04-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED THAT THEY HAD A MAGNETIC RESONANCE IMAGING (MRI) TEST EARLY IN THE DAY ON (B)(6) 2026, DURING WHICH TIME, THEY DISCONNECTED FROM THEIR TWIIST PUMP FOR APPROXIMALELY 45 MINUTES TO REMOVE IT FROM THE ROOM. UPON COMPLETION OF THE MRI, THE USER SUCCESSFULLY RESUMED THERAPY WITH A NEW CONTINUOUS GLUCOSE MONITOR (CGM) AND CLEO 90 INFUSION SET, STATING THAT THEIR BLOOD GLUCOSE WAS 165 MG/DL. THE USER THEN REPORTED THAT SINCE RESUMING THERAPY, THEIR GLUCOSE VALUES WERE ELEVATED, WITH VALUES REACHING UP TO 376MG/DL VIA FINGERSTICK. THE USER ATTEMPTED TO BOLUS VIA THE TWIIST PUMP, BUT NO CHANGE IN THEIR GLUCOSE VALUE WAS OBSERVED, PROMPTING THE USER TO CHANGE THEIR INFUSION SITE. THE USER CONFIRMED THAT THEY DID NOT RECEIVE ANY PUMP-RELATED ALARMS. THE USER REPORTED DIAPHORESIS AND FEELING "TINGLY" AND NERVOUS. THE USER PRESENTED TO THE EMERGENCY ROOM AND WAS TREATED WITH INTRAVENOUS FLUIDS, INSULIN, AND NAUSEA MEDICATION. DESPITE ELEVATED KETONES, THE USER WAS NOT DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE USER WAS DISCHARGED AFTER SIX HOURS AND RESUMED THERAPY ON THEIR TWIIST PUMP, REPORTING THAT THEIR GLUCOSE WAS 131 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187824 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other