Minimed™ Quick-set™ MMT-398A (UDI 05705244017917)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 infusion set for under-the-skin infusion, and its 505 reports often describe parts twisting or bending, leaks, and parts separating. Reports often list high blood sugar, and some list diabetic ketoacidosis, a condition in which blood acids build up. There are 3 deaths and 228 injuries reported, and no recalls name this device. Reports rose to 286 in the past year from 127 in the year 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
- 685
- Deaths reported
- 3
- Injuries reported
- 318
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 685 adverse event reports that list this exact device (DI 05705244017917), received between Apr 26, 2021 and Sep 30, 2026 — classified as 3 deaths, 318 injuries, 364 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (148 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
- Material Twisted/Bent148
- Adverse Event Without Identified Device or Use Problem140
- Loss of or Failure to Bond106
- Premature Separation92
- Leak/Splash84
- Complete Blockage52
- Use of Incorrect Control/Treatment Settings37
- Infusion or Flow Problem36
Patient problems
- No Clinical Signs, Symptoms or Conditions329
- Hyperglycemia239
- Elevated Ketones/ Diabetic Ketoacidosis82
- Hypoglycemia34
- Vomiting14
- Confusion/ Disorientation10
- Headache8
- Dizziness5
Recent adverse event reports
The 25 most recent of 685 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on (b)(6) 2026 in which infusion set fell from insertion site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950108 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936478 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935782 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935353 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932837 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927719 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced low blood glucose on (b)(6) 2026 which was treated by glucose intake.
Patient problems: Hypoglycemia
MAUDE report 50913822 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set tape not sticking due to hot and sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911345 ↗InjurySep 27, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50909875 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909841 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50909820 ↗InjurySep 27, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909769 ↗MalfunctionSep 27, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909649 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909503 ↗MalfunctionSep 26, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908372 ↗InjurySep 26, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50907968 ↗MalfunctionSep 26, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50907860 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907437 ↗InjurySep 26, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50907260 ↗InjurySep 26, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50907258 ↗InjurySep 26, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50907253 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906940 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906786 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose levels and treated with insulin pen event on(b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50896072 ↗InjurySep 25, 2026Complete Blockage; Material 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 and experienced Hyperglycemia treated with injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50894057 ↗
Other Set, Administration, Intravascular devices
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- 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.