Minimed™ Quick-set™ MMT-399A (UDI 05705244017498)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 is a Medtronic MiniMed Quick-Set infusion set, a single-use tube placed under the skin to deliver insulin. The 27 reports describe tubing and the cannula bending or twisting and blocking so insulin delivery stops, leading to high blood sugar that in one case required an injection; 19 people were injured and no deaths were reported. There are no recalls naming this device. All 27 reports came in the past 12 months, with none in the 12 months before that.
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
- 89
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 05705244017498), received between Apr 15, 2026 and Sep 30, 2026 — classified as 68 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (31 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 Problem38
- Material Twisted/Bent31
- Complete Blockage19
- Premature Separation13
- Loss of or Failure to Bond11
- Partial Blockage3
- Leak/Splash2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Hyperglycemia62
- No Clinical Signs, Symptoms or Conditions20
- Elevated Ketones/ Diabetic Ketoacidosis4
- Hypoglycemia4
- Dizziness1
- Polydipsia1
- Vomiting1
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50946378 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 476 mg/dL. The event lasted 3 to 4 hours and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946375 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 240 mg/dL. The event lasted less than 1 hour and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946373 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced an insulin flow blocked alarm, a bent infusion set cannula, and high blood glucose of 178 mg/dL. The high blood glucose persisted for 1 to 2 hours and was treated with a pump injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946370 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 450 mg/dL. The high blood glucose persisted for greater than 4 hours and was treated with insulin pens on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946276 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 438 mg/dL. The high blood glucose persisted for greater than 4 hours and was treated with a manual insulin injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946274 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and a high blood glucose event. The high blood glucose persisted for greater than 4 hours and was treated with an insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946270 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 300 mg/dL. The high blood glucose persisted for 3 to 4 hours and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946269 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced an insulin flow blocked alarm, a bent infusion set cannula, and high blood glucose of 178 mg/dL. The high blood glucose persisted for 1 to 2 hours and was treated with a pump injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946267 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 283 mg/dL. The high blood glucose persisted for greater than 4 hours and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946081 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 250 mg/dL. The event lasted less than 1 hour and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50942894 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula, resulting in a high blood glucose event of 400 mg/dL. The high blood glucose persisted for 3 to 4 hours and was treated with a correction bolus via the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50942796 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942316 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942289 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942286 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942276 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50930079 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929994 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929984 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929982 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929973 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929970 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced hyperglycemia event on (b)(6) 2026 and was treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50929965 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929959 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929956 ↗
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.