BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25262599 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00147
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 22, 2026
    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

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A SPECIFIC ROOT CAUSE FOR THE REPORTED LINE BLOCKED ALARMS CANNOT BE CONFIRMED. THE LINE BLOCKED ALARM IS IN PLACE TO ALERT THE USER THAT INSULIN IS BLOCKED FROM BEING DELIVERED, WHICH MAY OCCUR DUE TO A KINK IN THE INFUSION SET TUBING OR AT THE INFUSION SITE. THE INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION REGARDING SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE LINE BLOCKED ALARM, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. THE CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. NO ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAS 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 (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED THAT THEY RECEIVED REPEATED LINE BLOCKED ALARMS SINCE EXCHANGING THEIR CLEO 90 INFUSION SITE AND TWIIST CASSETTE THE NIGHT PRIOR. THE USER CHANGED THEIR INFUSION SITE AGAIN BUT WAS RESISTANT TO FURTHER TROUBLESHOOTING RECOMMENDATIONS. THE USER FURTHER STATED THAT THEIR GLUCOSE VALUES HAD INCREASED WHILE INSULIN DELIVERY WAS SUSPENDED DURING THE ALARMS AND RECEIVED ASSISTANCE FROM THEIR TRAINER TO BOLUS VIA THE PUMP, FOLLOWING WHICH, THEIR GLUCOSE VALUES TRENDED DOWN. REPORTABLE INFORMATION WAS THEN RECEIVED BY SEQUEL MED TECH, LLC, ON (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY INDICATING THAT THE USER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 WITH A GLUCOSE VALUE OVER 500 MG/DL. THE USER WAS PLACED ON AN INSULIN DRIP, FOLLOWING WHICH, THEIR GLUCOSE DECREASED TO 40 MG/DL. THE USER CONSUMED FOOD TO RESOLVE THE LOW GLUCOSE. THE USER FURTHER REPORTED THAT WHILE USING THE CLEO 90 INFUSION SET, THEY NOTICED THAT INSULIN HAD POOLED AND CREATED AN ABSCESS UNDER THEIR SKIN. THE USER WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026 AND ELECTED TO REMAIN DISCONNECTED FROM THEIR TWIIST PUMP UNTIL A REPLACEMENT COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205095 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007; DKPI-11073-001 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1