Minimed™ Quick-set™ MMT-399A (UDI 05705244017436)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 set for infusion under the skin. Of its 6,561 reports, 12 describe deaths and 3,072 describe injuries. Many describe tubing that is twisted or bent, parts that separate, and blocked flow, and patients often mention high blood sugar. Reports rose from 1,003 in the prior year to 4,531 in the latest year. No recalls name this device.
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
- 8,669
- Deaths reported
- 9
- Injuries reported
- 4,511
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,669 adverse event reports that list this exact device (DI 05705244017436), received between Oct 28, 2020 and Sep 30, 2026 — classified as 9 deaths, 4,511 injuries, 4,149 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2,254 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/Bent2,254
- Adverse Event Without Identified Device or Use Problem1,974
- Loss of or Failure to Bond1,259
- Premature Separation1,242
- Complete Blockage954
- Infusion or Flow Problem469
- Leak/Splash391
- Appropriate Device Problem Term/Code Not Available390
Patient problems
- Hyperglycemia4,039
- No Clinical Signs, Symptoms or Conditions3,407
- Elevated Ketones/ Diabetic Ketoacidosis802
- Hypoglycemia396
- Vomiting99
- Hemorrhage/Blood Loss/Bleeding64
- Nausea53
- Headache51
Recent adverse event reports
The 25 most recent of 8,669 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951924 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951808 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951537 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced high blood glucose of 437 mg/dL after the cannula was found bent on (b)(6) 2026. The high blood sugar was managed and treated with a correction bolus delivered via the insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50951265 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50951262 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50951082 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50951076 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950867 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949959 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949694 ↗InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50949419 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50949303 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949276 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948218 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948213 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was stated that patient reported hypoglycemia and was treated with Glucose Intake on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50947969 ↗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 50947955 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50947822 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent to 90 degrees on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947494 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent to 90 degrees on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947490 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced recurring Insulin Flow Blocked alarms on (b)(6) 2027, suggesting a possible occlusion, resulting in temporary use of insulin pen therapy until the issue was resolved.
Patient problems: Hyperglycemia
MAUDE report 50947489 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was used in one day resulted in bent cannula which led to occlusion on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947488 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947478 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent to 90 degrees on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947261 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the bent cannula resulted in Hyperglycemia led to tingling sensation on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947260 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 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
- 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.