twiist DKPI-11073-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00850017421431), received between Sep 5, 2025 and Sep 30, 2026 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Leak/Splash; Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954805 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954802 ↗
• MalfunctionSep 29, 2026Leak/Splash; Infusion or Flow Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939464 ↗
• MalfunctionSep 28, 2026Leak/Splash; Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924357 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924355 ↗
• MalfunctionSep 28, 2026Leak/Splash; Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924350 ↗
• MalfunctionSep 4, 2026Leak/Splash; Pumping Stopped; Wireless Communication Problem

  The user reported that they received a Pump Error alarm from their twiist Automated Insulin Delivery (AID) System. Upon removing the Cassette, the user noticed insulin within the Pump. The user reattached the Cassette, cleared the alarm, and was initially able to resume their insulin therapy. However, a few hours later, the user received the same Pump Error alarm followed by the system displaying a "Searching for Pump" message. The user attempted a Cassette and battery change, but reported that the Pump did not respond and the "chirp" when inserting the battery did not sound like it normally did. The user reverted to their backup insulin therapy while awaiting a replacement twiist Pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601168 ↗
• MalfunctionSep 4, 2026Leak/Splash; Pumping Stopped

  It was reported that the user received a Pump Error alarm from their twiist Automated Insulin Delivery (AID) System that they were unable to resolve. Upon removing the Cassette, the user's caregiver observed moisture inside the Pump and stated that it smelled like insulin. The user reverted to their backup insulin therapy while awaiting a replacement twiist Pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601164 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358722 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358720 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358718 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358717 ↗
• InjuryAug 20, 2026Detachment of Device or Device Component

  Patient problems: Hyperglycemia

  MAUDE report 50358716 ↗
• InjuryAug 20, 2026Detachment of Device or Device Component

  An initial event notification was received by Sequel Med Tech, LLC, on 17-MAR-2026 and forwarded to Millyard Advanced Medical Products, LLC, on the same day.The user reported that during the night, the tubing had detached from their twiist Cassette and they awoke with elevated glucose due to the event. The user reported a fingerstick value of 363 mg/dL and administered 12 units of insulin through a manual injection, following which, their glucose began trending downward. The user also stated that they would perform a Cassette change. The user remains ongoing on their twiist Pump.

  Patient problems: Hyperglycemia

  MAUDE report 50358715 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358714 ↗
• MalfunctionAug 19, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331755 ↗
• InjuryAug 19, 2026Detachment of Device or Device Component

  Patient problems: Hyperglycemia

  MAUDE report 50331754 ↗
• InjuryAug 19, 2026Detachment of Device or Device Component

  Patient problems: Hyperglycemia

  MAUDE report 50331753 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  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 the pigtail tubing detached from their twiist Cassette when they rolled over in their sleep. The user changed their Cassette and resumed therapy without issue. The user remains ongoing on their twiist Pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180970 ↗
• InjuryJun 19, 2026Lack of Effect

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC ON 20-MAY-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 21-MAY-2026. THE USER REPORTED THAT AFTER PERFORMING A CLEO 90 INFUSION SITE CHANGE, ON (B)(6) 2026, THEY DELIVERED A BOLUS FOR A SALAD CONSUMED AT LUNCH, FOLLOWING WHICH, THEIR BLOOD GLUCOSE (BG) "SKYROCKETED". THE USER DELIVERED AN ADDITIONAL BOLUS VIA THE TWIIST PUMP AND THEN CHANGED THEIR INFUSION SITE AND TWIIST CASSETTE; HOWEVER, NO CHANGE IN GLUCOSE WAS OBSERVED. THE USER THEN ADMINISTERED A MANUAL INJECTION OF INSULIN AND THEIR BG BEGAN TO DECLINE. LATER THAT DAY, THE USER'S BG ELEVATED BETWEEN 400-500 MG/DL AFTER CONSUMING ONLY PROTEIN AT DINNER. THE USER CHANGED THE INFUSION SITE AGAIN AND PRESENTED TO THE EMERGENCY DEPARTMENT (ED). THE USER REMAINED ON THE TWIIST PUMP DURING THIS TIME AND RECEIVED INTRAVENOUS FLUIDS, SALINE, AND AN EXOGENOUS INJECTION. AFTER A FEW HOURS, THE USER'S BG BEGAN TO DECLINE AND THE USER RETURNED HOME. THE USER DENIED DAMAGE/ISSUES WITH THE CLEO 90 INFUSION SETS, IRRITATION AT THE INFUSION SITES, ISSUES WITH THE TWIIST PUMP, AND LIFESTYLE CHANGES, AND WAS ADVISED TO CONTACT THEIR HEALTH CARE PROVIDER TO D

  Patient problems: Hyperglycemia

  MAUDE report 25566475 ↗
• MalfunctionJun 17, 2026Fluid/Blood Leak; Overheating of Device; Pumping Stopped; Wireless Communication Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC ON 18-MAY-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED RECEIVING A PUMP ERROR ALARM THAT THEY WERE UNABLE TO RESOLVE. THE USER ALSO REPORTED THAT WHEN THEY ATTEMPTED TO DISCONNECT THE CASSETTE FROM THE TWIIST PUMP, THE PUMP WAS "SO HOT IT BURNED" THEM; HOWEVER, THEY DENIED ANY INJURIES DUE TO THE HEAT OF THE PUMP. THE USER FURTHER CONFIRMED THE PRESENCE OF MOISTURE INSIDE THE PUMP, AND STATED THAT THEY WOULD REVERT TO MULTIPLE DAILY INJECTIONS AS THEIR BACKUP THERAPY PLAN WHILE AWAITING A REPLACEMENT PUMP.

  Patient problems: Skin Burning Sensation

  MAUDE report 25538734 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 12-MAY-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT THE PIGTAIL TUBING DETACHED FROM THE BODY OF THE TWIIST CASSETTE WHILE THEY WERE ASLEEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479343 ↗
• MalfunctionJun 5, 2026Material Separation

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-MAY-2026. THE USER REPORTED A HYPERGLYCEMIC EVENT WITH A GLUCOSE VALUE OF 401MG/DL ON (B)(6) 2026. THE USER REPORTED THAT THE TWIIST CASSETTE TUBING APPEARED TO HAVE BROKEN OFF NEAR THE LEUR LOCK CONNECTOR WHILE THEY WERE AT WORK AND THEY HAD NOT NOTICED THAT INSULIN WAS NOT BEING DELIVERED. THE USER CHANGED OUT THE TWIIST CASSETTE AND INFUSION SET TUBING. THE USER FURTHER STARTED THAT THEY WOULD TURN LOOP OFF, ADMINISTER A MANUAL INSULIN BOLUS OF 8 UNITS, AND CONTINUE TO MONITOR THEIR GLUCOSE VALUES. THE USER EXPERIENCED NAUSEA BUT CONFIRMED THEY DID NOT REQUIRE EMERGENCY MEDICAL SERVICES. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 25416711 ↗
• MalfunctionMay 22, 2026Loss of or Failure to Bond

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 23-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED ELEVATED GLUCOSE LEVELS AND, WHILE ATTEMPTING A CORRECTION BOLUS, OBSERVED THAT THE PIGTAIL TUBING HAD DETACHED FROM THE BODY OF THE TWIIST CASSETTE. THE USER REPORTED THAT THEIR GLUCOSE INCREASED TO 303 MG/DL BEFORE REPLACING THE CASSETTE AND ADMINISTERING EXOGENOUS INSULIN. NO MEDICAL INTERVENTION WAS REQUIRED. THE USER REMAINS ONGOING ON THE TWIIST PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 25262610 ↗
• MalfunctionMay 22, 2026Loss of or Failure to Bond

  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 INCREASING GLUCOSE VALUES. UPON INSPECTION, THE USER NOTED THAT THE PIGTAIL TUBING HAD DETACHED FROM THE BODY OF THE TWIIST CASSETTE. THE USER STATED THE CASSETTE HAD BEEN PLACED IN HER BRA AND DENIED ANY PULLING, FORCE, LEAKAGE, OR ALARMS ASSOCIATED WITH THE EVENT. BLOOD GLUCOSE INCREASED TO 358 MG/DL, CONFIRMED BY FINGERSTICK, AND SUBSEQUENTLY, SENSOR GLUCOSE WAS >400. THE USER REPORTED SYMPTOMS OF NAUSEA AND SHORTNESS OF BREATH BUT DENIED REQUIRING EMERGENCY MEDICAL SERVICES. THE USER REPLACED THE CASSETTE AND INFUSION SET TUBING AND WAS ABLE TO DELIVER A BOLUS VIA THE TWIIST PUMP. THE USER ALSO ADMINISTERED INHALED INSULIN (AFREZZA). THE USER REMAINS ONGOING ON THE TWIIST PUMP.

  Patient problems: Dyspnea; Hyperglycemia; Nausea

  MAUDE report 25262541 ↗