BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23325829 · Received October 17, 2025

    Report

    Report Number
    3016798778-2025-00124
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 15, 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
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO MDR#: 3016798778-2025-00124, SUBMITTED ON 17-OCT-2025. THIS SUBMISSION PROVIDES CORRECTIONS TO PREVIOUSLY REPORTED INFORMATION AND INCLUDES ADDITIONAL INFORMATION OBTAINED SINCE THE ORIGINAL SUBMISSION. THE ORIGINAL MDR WAS INCORRECTLY LABELED AS BOTH "INITIAL' AND "30-DAY" IN G6. FOR CLARIFICATION, THIS REPORT SHOULD HAVE BEEN LABELED ONLY AS A 30-DAY SERIOUS INJURY REPORT. THE REPORTABLE STATUS OF THE EVENT REMAINS UNCHANGED. NO CHANGES TO THE "DATE RECEIVED BY MANUFACTURER" (G3) ARE REQUIRED AS THE EVENT WAS ALREADY DETERMINED TO BE REPORTABLE BASED ON THE INITIAL INFORMATION RECEIVED. CHANGES TO THE IMDRF INVESTIGATION CODES (H6) WERE MADE TO REFLECT THE REVIEW OF LOG FILES AND INVESTIGATION RESULTS. INVESTIGATION PERFORMED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC: REVIEW OF SYSTEM LOGS CONFIRMED THAT THE USER'S GLUCOSE REACHED ABOVE THE MAXIMUM CGM (CONTINUOUS GLUCOSE MONITOR) VALUE OF 401G/DL ON 15-SEP-2025. ONE LINE BLOCKED ALARM OCCURRED ON (B)(6) 2025, WHICH APPEARED TO BE CONSISTENT WITH OCCLUSION-LIKE BEHAVIOR. TRANSIENT OCCLUSION-LIKE BEHAVIOR WAS ALSO OBSERVED THROUGHOUT THE TIMEFRAME OF THE COMPLAINT; HOWEVER, THE PUMP WAS DELIVERING THE TARGET VOLUME OF FLUID THROUGHOUT THIS TIMEFRAME, INDICATING THAT THE OCCLUSION-LIKE BEHAVIOR WAS EXTERNAL TO THE SYSTEM. FURTHER REVIEW OF THE LOGS SHOWED THAT THE SYSTEM WAS DELIVERING THE TARGET FLUID VOLUMES SUCCESSFULLY; BASAL RATE INCREASED APPROPRIATELY AS THE USER'S GLUCOSE INCREASED; BOLUSES WERE DELIVERED CORRECTLY DURING PERIODS OF ELEVATED GLUCOSE; AND BOLUS RECOMMENDATIONS WERE ISSUED AS INTENDED. THEREFORE, THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM OPERATED AS INTENDED TO ATTEMPT TO PREVENT A HYPERGLYCEMIC EVENT. NO SYSTEM FUNCTIONALITY ISSUES WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ELEVATED GLUCOSE OBSERVED WITHIN THE TIMEFRAME OF THE COMPLAINT.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 17-SEP-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED BEING ADMITTED TO THE HOSPITAL ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS. THE USER WAS DISCHARGED ON (B)(6) 2025. THE PATIENT REMAINS ONGOING ON THE TWIIST PUMP. ALTHOUGH NO SYSTEM ISSUE WAS IDENTIFIED, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION BECAUSE THE USER SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821405 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Hospitalization