BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23535028 · Received November 12, 2025

    Report

    Report Number
    3016798778-2025-00133
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 13, 2025
    Report Date
    February 27, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    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

    FOLLOW-UP TO MDR #3016798778-2025-00133, SUBMITTED ON 12-NOV-2025. THIS SUBMISSION PROVIDES CORRECTIONS TO PREVIOUSLY REPORTED INFORMATION AND INCLUDES ADDITIONAL INFORMATION OBTAINED SINCE THE ORIGINAL SUBMISSION. INVESTIGATION PERFORMED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC: ALTHOUGH THE REPORT OF SMOKE COULD NOT BE CONFIRMED, A LEAK WAS OBSERVED FROM THE CASSETTE'S RESERVOIR MEMBRANE (RM). UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, TWIIST PUMP, SERIAL NUMBER (B)(6), WAS UNABLE TO BE POWERED ON. THE PUMP WAS DISASSEMBLED AND EVIDENCE OF FLUID INGRESS WAS FOUND ON THE POWER AND COMMUNICATION CIRCUITS, CONSISTENT WITH THE POWER LOSS CONFIRMED IN THE LOG DATA AND THE REPORT OF A COMMUNICATION ISSUE. THE INVESTIGATION OF CASSETTE, SERIAL NUMBER (B)(6), CONFIRMED A LEAK IN THE RM. DISASSEMBLY REVEALED THAT THE LEAK ORIGINATED FROM A BUBBLE AND STRIATION IN THE RM. BUBBLES/STRIATIONS DEVELOP FROM MATERIAL VARIATIONS THAT RESULT IN LOCALIZED AREAS OF WEAKNESS UPON COMPLETION OF THE RM FORMING PROCESS AND CAN LEAD TO LEAKS WHEN THE CASSETTE IS FILLED WITH FLUID. THE CONTRACT DESIGNER AND MANUFACTURER WERE NOTIFIED OF THIS FINDING. BATTERY, SERIAL NUMBER (B)(6), WAS RETURNED WITH MINOR INGRESS ON THE EDGES OF THE BODY, BUT WAS DEEMED IRRELEVANT TO THIS REPORT AS IT FUNCTIONED AS INTENDED. THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM USER GUIDE EXPLAINS THAT THE SYSTEM IS COMPATIBLE WITH FAST-ACTING U-100 HUMALOG (INSULIN LISPRO) AND NOVOLOG (INSULIN ASPART). THIS GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. CORRECTIONS: THE ORIGINAL MDR WAS INCORRECTLY LABELED AS BOTH "INITIAL' AND "30-DAY." FOR CLARIFICATION, THIS REPORT SHOULD HAVE BEEN LABELED ONLY AS A 30-DAY MALFUNCTION REPORT. THE INVESTIGATION DETAILS PREVIOUSLY INCLUDED IN SECTION B5 OF THE ORIGINAL 30-DAY MDR FILED ON 12-NOV-2025 ARE NOW FULLY CAPTURED IN SECTION H11.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 13-OCT-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED FILLING A TWIIST CASSETTE WITH FIASP INSULIN AND THEN NOTICING THAT TWIIST PUMP (B)(6) WAS NOT COMMUNICATING WITH THE TWIIST APP. THE USER REMOVED THE CASSETTE AND FOUND THAT INSULIN HAD LEAKED INTO THE PUMP. THE USER TRIED TO INSERT A NEW BATTERY INTO THE PUMP, BUT THE PUMP BEGAN TO SMOKE. THE USER SUCCESSFULLY SWITCHED TO THEIR BACKUP INSULIN PLAN WHILE AWAITING A NEW TWIIST PUMP.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 13-OCT-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED FILLING A TWIIST CASSETTE WITH FIASP INSULIN AND THEN NOTICING THAT TWIIST PUMP, (B)(6), WAS NOT COMMUNICATING WITH THE TWIIST APP. THE USER REMOVED THE CASSETTE AND FOUND THAT INSULIN HAD LEAKED INTO THE PUMP. THE USER TRIED TO INSERT A NEW BATTERY INTO THE PUMP, BUT THE PUMP BEGAN TO SMOKE. THE USER SUCCESSFULLY SWITCHED TO THEIR BACKUP INSULIN PLAN WHILE AWAITING A NEW TWIIST PUMP. THE LAST AVAILABLE LOGS SHOW THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM FUNCTIONING AS INTENDED. HOWEVER, UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, TWIIST PUMP, (B)(6), WAS UNABLE TO BE POWERED ON. THE PUMP WAS DISASSEMBLED AND EVIDENCE OF FLUID INGRESS WAS FOUND ON THE POWER CIRCUIT, CONSISTENT WITH THE REPORT OF SMOKE. BATTERY, SERIAL NUMBER (B)(6), WAS RETURNED WITH MINOR INGRESS ON THE EDGES OF THE BODY BUT WAS ABLE TO CHARGE AS INTENDED. THE INVESTIGATION OF CASSETTE, SERIAL NUMBER (B)(6), REMAINS ONGOING. THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM USER GUIDE EXPLAINS THAT THE SYSTEM IS COMPATIBLE WITH FAST-ACTING U-100 HUMALOG (INSULIN LISPRO) AND NOVOLOG (INSULIN ASPART).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502173 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 58 YR Male