Minimed™ Quick-set™ MMT-396A (UDI 05705244018037)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 MiniMed Quick-set infusion set is a single-use set that delivers insulin under the skin. Many reports describe high blood sugar, and others describe bent or twisted parts, sets separating early, and leaks at the site. The FDA database lists 1,295 reports, with 669 injuries and 10 deaths, and reports rose in the last 12 months, to 973 from 198. No recalls name this device.
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
- 1,672
- Deaths reported
- 10
- Injuries reported
- 876
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,672 adverse event reports that list this exact device (DI 05705244018037), received between Jun 18, 2021 and Sep 30, 2026 — classified as 10 deaths, 876 injuries, 786 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (290 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
- Adverse Event Without Identified Device or Use Problem445
- Material Twisted/Bent290
- Premature Separation285
- Loss of or Failure to Bond270
- Leak/Splash149
- Complete Blockage144
- Appropriate Device Problem Term/Code Not Available67
- Detachment of Device or Device Component66
Patient problems
- Hyperglycemia748
- No Clinical Signs, Symptoms or Conditions687
- Elevated Ketones/ Diabetic Ketoacidosis139
- Hypoglycemia90
- Vomiting24
- Hemorrhage/Blood Loss/Bleeding19
- Headache11
- Pain11
Recent adverse event reports
The 25 most recent of 1,672 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950869 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent which led to the occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947964 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent which led to the occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947950 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50946784 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50946779 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pump event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50946777 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50946773 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946763 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946759 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946758 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product
It was reported that the patient faced an event where packaging reported as not sealed properly misshaped or sterile, packaging not intact on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944091 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the set tape fell down on 3rd day of insertion by mistakenly during swimming on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943265 ↗InjurySep 30, 2026Fluid/Blood Leak
On (b)(6) 2026, the infusion set leaked directly at the insertion site, causing the patient's blood sugar to rise to 17 mmol/L. The patient treated the high blood sugar by insulin pens.
Patient problems: Hyperglycemia
MAUDE report 50942600 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hyperglycemic episode on (b)(6) 2026 measuring of 26 mmol/L, which was successfully managed with self-administered treated bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50942306 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hypoglycemic episode on (b)(6) 2026, which was successfully managed with treated by food intake that is Carbs.
Patient problems: Hypoglycemia
MAUDE report 50942212 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932449 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a high glucose level of 400 mg/dl on (b)(6)2026, approximately three to four hours after the infusion set had been placed on the abdomen on Day 1. The patient was treated with an insulin injection.
Patient problems: Hyperglycemia
MAUDE report 50932386 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia
MAUDE report 50932385 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929164 ↗InjurySep 29, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50929109 ↗InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50928714 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50928594 ↗InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50927827 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927806 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927744 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page