Quick-set® Paradigm® MMT-399 (UDI 05705244006331)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Quick-set Paradigm infusion set is a single-use tube that delivers insulin under the skin. Most of the 591 reports describe the set coming off or bending, or insulin flow being blocked, and many mention high blood sugar and ketone buildup in patients. The reports include 136 injuries and no deaths. Reports rose from 54 in the previous 12 months to 124 in the latest 12 months. 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
- 620
- Deaths reported
- 0
- Injuries reported
- 155
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 620 adverse event reports that list this exact device (DI 05705244006331), received between Dec 12, 2017 and Sep 27, 2026 — classified as 155 injuries, 465 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (293 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
- Detachment of Device or Device Component293
- Material Twisted/Bent109
- Adverse Event Without Identified Device or Use Problem52
- Infusion or Flow Problem52
- Complete Blockage35
- Loss of or Failure to Bond32
- Leak/Splash26
- Material Deformation19
Patient problems
- No Known Impact Or Consequence To Patient190
- No Clinical Signs, Symptoms or Conditions182
- Hyperglycemia146
- Elevated Ketones/ Diabetic Ketoacidosis91
- Hypoglycemia9
- Vomiting7
- Pain4
- Loss of consciousness2
Recent adverse event reports
The 25 most recent of 620 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909652 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906950 ↗MalfunctionSep 24, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient had experienced infusion set bent cannula that cause high blood glucose level event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50878859 ↗MalfunctionSep 23, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient experienced an event on 23 Aug 2026 where bent cannula led to an occlusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864210 ↗InjurySep 23, 2026Complete Blockage
It was reported that patient experienced an event on (b)(6)2026 where bent cannula led to an occlusion which led to high blood glucose and was treated by pump.
Patient problems: Hyperglycemia
MAUDE report 50864205 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient face issue of high blood glucose level treated with manual injection on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50839018 ↗MalfunctionSep 21, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839014 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient face issue of high blood glucose level treated with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50838864 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient face issue of high blood glucose level which was treated with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50838857 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50833929 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828024 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825955 ↗InjurySep 18, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50824681 ↗InjurySep 18, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50824616 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50823095 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fatigue; Hyperglycemia; Vomiting
MAUDE report 50821411 ↗InjurySep 16, 2026Obstruction of Flow; Appropriate Device Problem Term/Code Not Available
It was reported that the patient faced possible set occlusion event on (b)(6) 2026. The blood glucose was high at the time of event and treated via pump and manual injection.
Patient problems: Hyperglycemia
MAUDE report 50783266 ↗InjurySep 16, 2026Obstruction of Flow; Appropriate Device Problem Term/Code Not Available
It was reported that the patient faced occlusion event on (b)(6) 2026. The blood glucose was high at the time of event and treated via manual injections.
Patient problems: Hyperglycemia
MAUDE report 50783076 ↗MalfunctionSep 14, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced infusion set bent cannula led to an occlusion, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749671 ↗MalfunctionSep 12, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745721 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 350mg/dL high for more than four hours and the patient was treated with correction bolus 780g insulin pump administration.
Patient problems: Hyperglycemia
MAUDE report 50673834 ↗MalfunctionSep 8, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50664721 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced High Blood Glucose values for approximately 1¿2 hours on (b)(6) 2026 and required treatment with pump administration of insulin and manual injections.
Patient problems: Hyperglycemia
MAUDE report 50664622 ↗InjurySep 8, 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 insulin via pump.
Patient problems: Hyperglycemia
MAUDE report 50664377 ↗InjurySep 8, 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 insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50664373 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page