BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24847650 · Received April 11, 2026

    Report

    Report Number
    3016798778-2026-00091
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 15, 2026
    Report Date
    April 10, 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

    A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. ALTHOUGH THE USER'S HYPERGLYCEMIA WAS ATTRIBUTED TO A KINKED CLEO 90 INFUSION SET CANNULA, HYPERGLYCEMIA IS CAPTURED IN SECTION H6 DUE TO THE REPORT THAT NO ALARM WAS HEARD TO NOTIFY THE USER OF ELEVATED BLOOD GLUCOSE. THE CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE EXPLAINS THAT AN URGENT LOW GLUCOSE ALERT NOTIFIES THE USER WHEN THEIR SENSOR GLUCOSE READING GOES BELOW 55 MG/DL. THE URGENT LOW GLUCOSE ALERT CANNOT BE DISABLED AND IS ALWAYS PLAYED BY THE IPHONE EVEN WHEN THE IPHONE IS SILENCED OR FOCUS IS ENABLED. THE LOW GLUCOSE ALERT IS ON BY DEFAULT AND IS INITIALLY SET TO 70 MG/DL BUT CAN BE SET BETWEEN 60-100 MG/DL IN 5 MG/DL INCREMENTS. OVERRIDE FOCUS IS TURNED ON BY DEFAULT TO ENABLE THE LOW GLUCOSE ALERT TO ALWAYS PLAY A SOUND AND APPEAR ON THE LOCK SCREEN EVEN IF THE IPHONE IS MUTED OR FOCUS IS ON. THE CGM HIGH GLUCOSE ALERT IS ON BY DEFAULT, AND IS INITIALLY SET TO 250 MG/DL. THE USER GUIDE EXPLAINS THAT ONLY ONE CGM HIGH GLUCOSE ALERT WILL BE TRIGGERED PER HIGH GLUCOSE EPISODE. THIS GUIDE ALSO WARNS, "DO NOT TAKE EXTERNAL INSULIN, SUCH AS MANUAL INSULIN INJECTIONS OR INHALED INSULINS, WHILE LOOP IS ON AND THE TWIIST PUMP IS OPERATIONAL. THE TWIIST AID SYSTEM DOES NOT RECEIVE INFORMATION ABOUT INSULIN TAKEN OUTSIDE THE SYSTEM. IF YOU CHOOSE TO TAKE ADDITIONAL INSULIN WITH ANOTHER METHOD WHILE LOOP IS ON AND THE TWIIST PUMP IS WORKING, OVER-DELIVERY OR UNDER-DELIVERY OF INSULIN MAY OCCUR, WHICH CAN LEAD TO HIGH AND LOW GLUCOSE." IT IS ALSO EXPLAINED THAT IF LOOP IS ON AND CGM SIGNAL LOSS OCCURS, THE TWIIST AID SYSTEM WILL NOT BE ABLE TO COMPLETE A LOOP IN ORDER TO ADJUST BASAL DELIVERY. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 16-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED HAVING AN ELEVATED BLOOD GLUCOSE VALUE OF 550 MG/DL ON THE EVENING OF (B)(6) 2026 DUE TO A KINKED CLEO 90 INFUSION SET CANNULA AND NOTED THAT NO AUDIO ALERTS WERE HEARD. THE USER ADMINISTERED A MANUAL INJECTION OF 9 UNITS OF INSULIN TO CORRECT THEIR BLOOD GLUCOSE AND DUPLICATED THIS DOSE WHILE DISCONNECTED FROM THE TWIIST PUMP TO TRACK ACTIVE INSULIN. THE USER FURTHER REPORTED THAT THEIR GLUCOSE WAS STILL ELEVATED A FEW HOURS LATER, WHEN THEY WENT TO BED. DURING THE NIGHT, THE USER GOT UP, ATE A SMALL AMOUNT OF DESSERT, ADMINISTERED ANOTHER MANUAL INJECTION OF INSULIN, AND ENTERED 5 GRAMS OF CARBOHYDRATES INTO THE TWIIST APP. THE USER THEN EXPERIENCED A SIGNAL LOSS EVENT BETWEEN THE TWIIST PUMP AND ABBOTT FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITOR (CGM), WHICH THE USER ATTRIBUTED TO A POSSIBLE COMPRESSION LOW FROM SLEEPING ON THE CGM. THE USER SUBSEQUENTLY EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 42 MG/DL, NOTING AGAIN THAT THEY DID NOT HEAR ANY AUDIO ALARMS OR ALERTS. THE PATIENT REPORTED DIAPHORESIS, FEELING FAINT, BEING UNABLE TO WALK, AND VOMITING. THE USER'S SPOUSE GAVE THEM APPLE JUICE AND CALLED EMERGENCY MEDICAL SERVICES (EMS). UPON ARRIVAL, EMS RECORDED A BODY TEMPERATURE OF 94.1°F, A BLOOD PRESSURE OF 97/56 MMHG, AND A HEART RATE OF 75 BPM. THE USER WAS PROVIDED WITH GLUCOSE PASTE BUT WAS TRANSPORTED TO THE EMERGENCY ROOM FOR INTRAVENOUS FLUIDS DUE TO CONCERNS OVER SLOW GLUCOSE RECOVERY. THE USER WAS RELEASED 3 HOURS LATER ONCE THEIR GLUCOSE HAD RECOVERED AND REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE USER LATER REPORTED THAT THEY WERE NOT RECEIVING OTHER NOTIFICATIONS ON THEIR IPHONE AND ULTIMATELY REPLACED THE PHONE IN USE DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295117 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other