Minimed™ Quick-set™ MMT-397A (UDI 05705244017559)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 infusion set is a single-use tube set that delivers fluid under the skin and is used with an insulin pump. Its 3,306 reports mostly describe leaks, bent or twisted tubing, parts coming apart and blocked flow, with patients reporting high blood sugar and ketoacidosis. The reports include 17 deaths and 1,429 injuries, and no recalls name this device. Reports rose sharply in the most recent year (1,901) from the year before (719).
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
- 4,134
- Deaths reported
- 19
- Injuries reported
- 1,863
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,134 adverse event reports that list this exact device (DI 05705244017559), received between Aug 5, 2020 and Sep 30, 2026 — classified as 19 deaths, 1,863 injuries, 2,252 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (608 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 Problem1,031
- Loss of or Failure to Bond608
- Material Twisted/Bent587
- Premature Separation587
- Leak/Splash520
- Detachment of Device or Device Component268
- Infusion or Flow Problem256
- Complete Blockage220
Patient problems
- No Clinical Signs, Symptoms or Conditions1,922
- Hyperglycemia1,428
- Elevated Ketones/ Diabetic Ketoacidosis455
- Hypoglycemia295
- Vomiting39
- Hemorrhage/Blood Loss/Bleeding38
- Headache28
- Fatigue27
Recent adverse event reports
The 25 most recent of 4,134 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 50951555 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced high blood glucose (BG) of 420 mg/dL after the cannula was found bent. The high blood sugar was managed and treated with insulin delivered via the insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50951267 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent cannula event on (b)(6)2026 that resulted in high blood glucose. The high blood sugar was managed and treated with a bolus.
Patient problems: Hyperglycemia
MAUDE report 50951264 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50951079 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced an event on 28 Aug 2026 in which infusion set was pulled while changing clothes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950458 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949600 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949592 ↗InjurySep 30, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50949274 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949273 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949073 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948722 ↗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 50948365 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent led to skin irritation on (b)(6) 2026.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50947961 ↗InjurySep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50947831 ↗MalfunctionSep 30, 2026Partial 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 led to occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947263 ↗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 480 mg/dl with high ketones and hospitalize in emergency room by treated with insulin drip event on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50946895 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50946765 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent cannula event on (b)(6) 2026 that resulted in hyperglycemia. The high blood glucose was treated with a bolus.
Patient problems: Hyperglycemia
MAUDE report 50945928 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced an infusion set leak at the cannula site, which resulted in high blood glucose (BG) levels on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50945671 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50945658 ↗InjurySep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set was leaking at the tubing on (b)(6) 2026. The blood glucose was high and was treated via pump.
Patient problems: Hyperglycemia
MAUDE report 50945654 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50945653 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that the patient faced infusion Set Tubing Detachment on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945550 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that the patient faced infusion Set Tubing Detachment on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945549 ↗DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was dead due to unknown reason on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944805 ↗
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
- Autosoft XC 1006922Unomedical A/S · Set, Administration, Intravascular3,990 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.