BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24987449 · Received April 24, 2026

    Report

    Report Number
    3016798778-2026-00105
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 24, 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 IT WAS REPORTED THAT A DIABETES EDUCATOR AT THE HOSPITAL SUSPECTED A POTENTIAL INFUSION SITE ISSUE, "INFUSION OR FLOW PROBLEM" IS CAPTURED AS A MEDICAL DEVICE PROBLEM CODE IN SECTION H6 PENDING INVESTIGATION RESULTS. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE EXPLAINS THAT THE CONTINUOUS GLUCOSE MONITOR (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. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. 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 25-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. IT WAS REPORTED THAT THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE FOLLOWING A CLEO 90 INFUSION SET CHANGE THE NIGHT BEFORE. THE USER'S CAREGIVER REPORTED THAT NO HIGH GLUCOSE ALARMS WERE RECEIVED OVERNIGHT; HOWEVER, THE USER'S CONTINOUS GLUCOSE MONITOR READING WAS "HIGH" (>400 MG/DL) AND THEY BEGAN VOMITING. UPON INSTRUCTION FROM THEIR ENDOCRINOLOGIST, THE USER PRESENTED TO THE EMERGENCY ROOM (ER) MID-AFTERNOON, AND THE TWIIST PUMP WAS REMOVED. ALTHOUGH THE USER'S CAREGIVER REPORTED THAT AN INSPECTION OF THE TWIIST PUMP AND SUPPLIES SHOWED NO OBVIOUS DEFECTS, A HOSPITAL DIABETES EDUCATOR SUSPECTED A POTENTIAL INFUSION SITE ISSUE. FOLLOWING TREATMENT VIA INTRAVENOUS FLUIDS AND INSULIN, THE USER'S BLOOD GLUCOSE STABILIZED TO 98 MG/DL, KETONES DECREASED, AND THE TWIIST PUMP WAS SUCCESSFULLY RESTARTED AT A NEW INFUSION SITE ON THE OPPOSITE SIDE OF THE ABDOMEN. THE USER WAS DISCHARGED THE FOLLOWING MORNING. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474937 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention| H