BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24541638 · Received March 7, 2026

    Report

    Report Number
    3016798778-2026-00050
    Event Type
    Malfunction
    Date Received
    March 7, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 7, 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

    REVIEW OF LOG DATA CONFIRMED THE REPORT OF PUMP ERROR ALARMS. UPON DISASSEMBLY OF TWIIST PUMP, SERIAL NUMBER (B)(6), A COMPONENT FAILURE ASSOCIATED WITH A KNOWN MANUFACTURING ISSUE WAS IDENTIFIED, CONSISTENT WITH THE PUMP ERROR ALARMS. UPDATES WERE PREVIOUSLY IMPLEMENTED TO PREVENT THIS TYPE OF FAILURE FROM RECURRING; TWIIST PUMP, SERIAL NUMBER (B)(6), WAS MANUFACTURED PRIOR TO THOSE UPDATES. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THIS GUIDE ALSO INSTRUCTS USERS TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. ALTHOUGH THE USER REPORTED THAT THE NAUSEA THEY EXPERIENCED DURING THE REPORTED EVENT MAY HAVE BEEN RELATED TO AN ONCOMING ILLNESS, IT IS INCLUDED IN THIS MEDICAL DEVICE REPORT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 05-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, THAT SAME DAY. THE USER REPORTED RECEIVING A PUMP ERROR ALARM ON (B)(6) 2026 THAT THEY COULD NOT RESOLVE. THE USER DID NOT HAVE BACKUP INSULIN AVAILABLE, AND THEIR BLOOD GLUCOSE INCREASED ABOVE 500 MG/DL OVERNIGHT. ON (B)(6) 2026, THE USER REPORTED EXPERIENCING NAUSEA BUT STATED THAT IT MIGHT BE RELATED TO AN ONCOMING ILLNESS. THE USER WAS ULTIMATELY ABLE TO OBTAIN SEMI-LONG-ACTING INSULIN AND DID NOT NEED ADDITIONAL INTERVENTION. TWIIST PUMP, SERIAL NUMBER (B)(6), WAS REPLACED. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602525 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other