Minimed™ Quick-set™ MMT-394A (UDI 05705244017313)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
Quick summary
This Medtronic MiniMed Quick-set infusion set is a single-use tube that delivers insulin under the skin. Many of its 208 reports describe the set coming apart or the adhesive tape failing to stick, and some mention kinks, flow problems or leaks. The reports include 1 death and 70 injuries. No recalls name this device. Reports rose to 125 in the last 12 months, from 43 in the 12 months before.
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
- 274
- Deaths reported
- 1
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 05705244017313), received between Nov 19, 2020 and Sep 30, 2026 — classified as 1 death, 119 injuries, 154 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (58 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 Problem61
- Premature Separation58
- Loss of or Failure to Bond48
- Material Twisted/Bent48
- Complete Blockage27
- Infusion or Flow Problem24
- Detachment of Device or Device Component20
- Leak/Splash20
Patient problems
- No Clinical Signs, Symptoms or Conditions139
- Hyperglycemia91
- Elevated Ketones/ Diabetic Ketoacidosis31
- Hypoglycemia13
- Vomiting11
- Malaise5
- Coma2
- Nausea2
Recent adverse event reports
The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for one day resulted in bent cannula led to Hyperglycemia on (b)(6) 2026. The high blood glucose measured was 400mg/dl.
Patient problems: Hyperglycemia
MAUDE report 50947834 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was used for one day resulted in bent cannula with Hyperglycemia and bruising at site on (b)(6) 2026.
Patient problems: Bruise/Contusion; Hyperglycemia
MAUDE report 50947832 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that the patient faced detachment of tubing from the quick release on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945651 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that the patient faced detachment in quick release which caused to the tubing to detach on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945554 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026. The patient was treated with manual injections and the glucose level had been high for more than four hours.
Patient problems: Hyperglycemia
MAUDE report 50941855 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932401 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910097 ↗MalfunctionSep 26, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907866 ↗InjurySep 26, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia; Vomiting
MAUDE report 50907161 ↗MalfunctionSep 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906783 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50906769 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50906768 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50906737 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced insulin flow blocked alarm due to infusion set cannula was bent event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895348 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced elevated blood glucose on (b)(6)2026, which were treated by insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50852533 ↗MalfunctionSep 22, 2026Material Twisted/Bent
It was reported that the patient infusion set cannula was bent which leads to high blood glucose on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50850923 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had experienced a high blood glucose event on (b)(6) 2026 and was treated with Pump and injection.
Patient problems: Hyperglycemia
MAUDE report 50850919 ↗MalfunctionSep 21, 2026Complete Blockage
It was reported that patient received occlusion alarms on (b)(6)2026, upon troubleshooting blockage was identified in the infusion set tubing and insulin did not exit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836631 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834359 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834354 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834302 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834285 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834284 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50833885 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50833881 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.