Quick-set® Paradigm® MMT-396 (UDI 05705244006775)Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Quick-set Paradigm infusion set is a single-use tubing set that delivers insulin under the skin from a pump. Many of its 189 reports describe the set coming off, and many note high blood sugar, with some noting diabetic ketoacidosis. There are 28 injury reports and 2 death reports. No recalls name this device. Reports rose from 7 in the year before to 18 in the latest year.
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
- 205
- Deaths reported
- 2
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 05705244006775), received between May 24, 2018 and Sep 30, 2026 — classified as 2 deaths, 41 injuries, 162 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (146 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component146
- Adverse Event Without Identified Device or Use Problem26
- Material Twisted/Bent15
- No Apparent Adverse Event6
- Connection Problem5
- Premature Separation4
- Leak/Splash3
- Loss of or Failure to Bond3
Patient problems
- No Known Impact Or Consequence To Patient80
- Hyperglycemia69
- No Clinical Signs, Symptoms or Conditions29
- Elevated Ketones/ Diabetic Ketoacidosis20
- Hypoglycemia5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Headache2
- Abdominal Pain1
Recent adverse event reports
The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Separation
It was reported by the patient that infusion set detaches from the body and falls off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945445 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that their infusion set detaches from body and falls off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943264 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907816 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall; Hypoglycemia
MAUDE report 50907013 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834212 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834000 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823109 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823098 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823066 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823056 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627280 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627279 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627277 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627276 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627275 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50627274 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
Patient reported high blood glucose levels, treatment provided was manual insulin on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50524016 ↗InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50511253 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a high blood glucose level of 280 mg/dL, treated with an insulin injection and pump therapy, and also experienced bleeding at the infusion site on (b)(6) 2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia
MAUDE report 50470359 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249021 ↗MalfunctionAug 8, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187120 ↗MalfunctionAug 7, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173247 ↗MalfunctionAug 7, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173240 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had high blood glucose and treated with the insulin injection event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50109865 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had high blood glucose and treated with the insulin injection event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50109861 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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