Quick-set ParadigmRecalls & reported problems across all models
Unomedical A/S · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,783
- Deaths reported
- 19
- Injuries reported
- 366
- Recalls
- 0
We found 23 models of Quick-set Paradigm by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 1,783 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2017 and Sep 30, 2026 — classified as 19 deaths, 366 injuries, 1,398 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1,151 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quick-set Paradigm problems
Device problems
- Detachment of Device or Device Component1,151
- Material Twisted/Bent241
- Adverse Event Without Identified Device or Use Problem119
- Infusion or Flow Problem73
- Loss of or Failure to Bond53
- Leak/Splash43
- Complete Blockage37
- Premature Separation33
Patient problems
- No Known Impact Or Consequence To Patient734
- Hyperglycemia422
- No Clinical Signs, Symptoms or Conditions331
- Elevated Ketones/ Diabetic Ketoacidosis258
- Hypoglycemia28
- Death12
- Vomiting8
- Coma5
Quick-set Paradigm models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quick-set® Paradigm® MMT-399Set, Administration, Intravascular620 reports
- Quick-set® Paradigm® MMT-397Set, Administration, Intravascular11 deaths609 reports
- Quick-set® Paradigm® MMT-396Set, Administration, Intravascular2 deaths205 reports
- Quick-set® Paradigm® MMT-386Set, Administration, Intravascular1 death95 reports
- Quick-set® Paradigm® MMT-398Set, Administration, Intravascular70 reports
- Quick-set® Paradigm® MMT-387Set, Administration, Intravascular2 deaths63 reports
- Quick-set® Paradigm® MMT-394Set, Administration, Intravascular3 deaths30 reports
- Quick-set® Paradigm® MMT-399600Set, Administration, Intravascular26 reports
- Quick-set® Paradigm® MMT-397600Set, Administration, Intravascular21 reports
- Quick-set® Paradigm® MMT-394Set, Administration, Intravascular7 reports
- Quick-set® Paradigm® MMT-396600Set, Administration, Intravascular7 reports
- Quick-set® Paradigm® MMT-398600Set, Administration, Intravascular5 reports
- Quick-set® Paradigm® MMT-399TSet, Administration, Intravascular5 reports
- Quick-set® Paradigm® MMT-399TSet, Administration, Intravascular5 reports
- Quick-set® Paradigm® MMT-387600Set, Administration, Intravascular4 reports
- Quick-set® Paradigm® MMT-394600Set, Administration, Intravascular3 reports
- Quick-set® Paradigm® MMT-399Set, Administration, Intravascular2 reports
- Quick-set® Paradigm® MMT-397Set, Administration, Intravascular1 report
- Quick-set® Paradigm® MMT-386600Set, Administration, Intravascular1 report
- Quick-set® Paradigm® MMT-396Set, Administration, Intravascular1 report
- Quick-set® Paradigm® MMT-397TSet, Administration, Intravascular1 report
- Quick-set® Paradigm® MMT-396TSet, Administration, Intravascular1 report
- Quick-set® Paradigm® MMT-398TSet, Administration, Intravascular1 report
Recent Quick-set Paradigm adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Separation
It was reported by the patient that infusion set detaches from the body and falls off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945445 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that their infusion set detaches from body and falls off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943264 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932416 ↗MalfunctionSep 27, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909652 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907816 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall; Hypoglycemia
MAUDE report 50907013 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906950 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient had Low blood glucose 70mg/dl and treated with juice or glucose tablets on (b)(6)2026.
Patient problems: Hypoglycemia
MAUDE report 50895391 ↗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 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- MiniMed Infusion Sets58 models · 30,240 reports
- Medtronic Extended27 models · 22,785 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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