Minimed™ Quick-set™ MMT-386A (UDI 05705244017795)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 MiniMed Quick-set is a single use tube set that delivers insulin under the skin. Of its 320 reports, 222 are malfunctions and 96 are injuries, often describing the set detaching or coming apart, leaking, and blocked insulin flow. The reports mention 2 deaths, and some involve high or low blood sugar and diabetic ketoacidosis. No recalls name this device. Reports rose to 188 in the last 12 months from 62 in the previous 12.
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
- 411
- Deaths reported
- 2
- Injuries reported
- 116
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 411 adverse event reports that list this exact device (DI 05705244017795), received between Dec 3, 2020 and Sep 30, 2026 — classified as 2 deaths, 116 injuries, 293 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (105 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
- Loss of or Failure to Bond105
- Premature Separation94
- Adverse Event Without Identified Device or Use Problem77
- Detachment of Device or Device Component51
- Infusion or Flow Problem40
- Material Twisted/Bent31
- Leak/Splash30
- Complete Blockage22
Patient problems
- No Clinical Signs, Symptoms or Conditions268
- Hyperglycemia84
- Elevated Ketones/ Diabetic Ketoacidosis37
- Hypoglycemia25
- Vomiting6
- Dehydration2
- Loss of consciousness2
- Nausea2
Recent adverse event reports
The 25 most recent of 411 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 50951638 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951377 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to sweating on (b)(4) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951374 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948592 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
It was reported that the patient experienced infusion set tubing detachment causing high blood glucose levels and event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946878 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set came tape was not sticking due to sweat event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941889 ↗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 50941854 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936127 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936121 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event with infusion set where infusion set tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931234 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931089 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931088 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced hyperglycemia, which persisted for greater than four hours and was treated with insulin administered via an insulin pen, on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50915567 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced adhesive issues on (b)(6) 2026 as infusion set came off due to sticky part not working at all.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911569 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50909989 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909983 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908130 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907444 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907004 ↗MalfunctionSep 25, 2026Leak/Splash
It was reported that the patient experienced a leakage at the infusion set insertion site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894603 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where infusion set tape was not sticking due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864065 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where infusion set tape was not sticking due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864057 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced issue with tape not sticking due to sweating on(b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841756 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced issue with tape not sticking due to sweating on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841748 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841745 ↗
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.