twiist DKPI-21073-007Recalls & reported problems
Sequel Med Tech, LLC · twiist Pump Assembly, Labeled · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This twiist insulin pump is an automated device that delivers insulin. Many reports describe the pump stopping, blocked flow, or insulin having little effect, and reports mention high blood sugar, high ketone levels or low blood sugar. The 158 reports include no deaths and 120 injuries. No recalls name this device, and reports rose from 3 in the prior 12 months to 155 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00850017421400), received between Aug 19, 2025 and Sep 30, 2026 — classified as 117 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (36 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information36
- Pumping Stopped25
- Obstruction of Flow23
- Lack of Effect21
- Infusion or Flow Problem14
- Insufficient Flow or Under Infusion13
- Adverse Event Without Identified Device or Use Problem11
- Wireless Communication Problem8
Patient problems
- Hyperglycemia86
- Elevated Ketones/ Diabetic Ketoacidosis48
- Hypoglycemia40
- No Clinical Signs, Symptoms or Conditions22
- Vomiting22
- Nausea16
- Diaphoresis9
- Confusion/ Disorientation8
Recent adverse event reports
The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash; Pumping Stopped; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954804 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954803 ↗MalfunctionSep 30, 2026Pumping Stopped; Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954801 ↗MalfunctionSep 30, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954800 ↗MalfunctionSep 30, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954799 ↗MalfunctionSep 30, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954798 ↗MalfunctionSep 30, 2026Pumping Stopped; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954797 ↗MalfunctionSep 29, 2026Leak/Splash; Pumping Stopped; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939495 ↗InjurySep 29, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50939490 ↗InjurySep 29, 2026Pumping Stopped
Patient problems: Hyperglycemia
MAUDE report 50939485 ↗MalfunctionSep 29, 2026Leak/Splash; Pumping Stopped; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939483 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939479 ↗MalfunctionSep 29, 2026Leak/Splash; Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939475 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939472 ↗MalfunctionSep 28, 2026Pumping Stopped
The user reported that they received a Pump Error alarm from their twiist Automated Insulin Delivery (AID) System that they were unable to resolve. The user reverted to a backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924365 ↗MalfunctionSep 28, 2026Leak/Splash; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924360 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924352 ↗MalfunctionSep 4, 2026Pumping Stopped
The user reported that they received a Pump Error from their twiist Automated Insulin Delivery (AID) System that they were unable to resolve. The user reverted to a backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601193 ↗MalfunctionSep 4, 2026Pumping Stopped
The user reported that they received a Pump Error from their twiist Automated Insulin Delivery (AID) System that they were unable to resolve. The user reverted to a backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601189 ↗MalfunctionSep 4, 2026Pumping Stopped
The user reported that they received Pump Error alarms from their twiist Automated Insulin Delivery (AID) System that they were unable to resolve. The user reverted to their backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601185 ↗MalfunctionAug 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508812 ↗MalfunctionAug 25, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439549 ↗InjuryAug 24, 2026Pumping Stopped
An initial event notification was received by Sequel Med Tech, LLC on 25-JUL-2026 and forwarded to Millyard Advanced Medical Products, LLC on the same day.The user reported that they received Pump Error alarms from their twiist Automated Insulin Delivery (AID) system. The user's glucose at the time of the alarms was 270 mg/dL. The user gave themselves an injection of Lyumjev (insulin lispro) to resolve their glucose and reverted to their backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: Hyperglycemia
MAUDE report 50417476 ↗InjuryAug 21, 2026Pumping Stopped
An initial event notification was received by Sequel Med Tech, LLC, on 28-MAR-2026 and forwarded to Millyard Advanced Medical Products, LLC, on the same day.The user reported that they received a Pump Error from their twiist Automated Insulin Delivery (AID) System. The user's glucose at the time of the alarm was 384 mg/dL. The user reverted to a backup insulin therapy while awaiting a replacement twiist Pump.
Patient problems: Hyperglycemia
MAUDE report 50379330 ↗MalfunctionAug 19, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331759 ↗
Other Interoperable Automated Glycemic Controller devices
- iLet Bionic Pancreas Insulin OnlyBeta Bionics, Inc. · Interoperable Automated Glycemic Controller2 deaths9,393 reports
- iLet Bionic Pancreas Insulin OnlyBeta Bionics, Inc. · Interoperable Automated Glycemic Controller5 deaths5,718 reports
- t:slim X2 Insulin Pump with Control-IQ 1005012Tandem Diabetes Care, Inc. · Interoperable Automated Glycemic Controller1 recall4,129 reports
- iLet Bionic Pancreas Insulin OnlyBeta Bionics, Inc. · Interoperable Automated Glycemic Controller1 death1,822 reports
- twiist DKPI-11073-001Sequel Med Tech, LLC · Interoperable Automated Glycemic Controller29 reports
- iLet Starter Kit - Contact Detach Insulin OnlyBeta Bionics, Inc. · Interoperable Automated Glycemic Controller3 reports
- iLet Bionic Pancreas Insulin OnlyBeta Bionics, Inc. · Interoperable Automated Glycemic Controller1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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