Quick-set® Paradigm® MMT-397 (UDI 05705244006416)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 Unomedical Quick-set Paradigm is a single-use infusion set for subcutaneous use. Of the 606 reports naming it, most describe parts detaching from the set, with some patients reporting high blood glucose or ketone build-up. The reports include 112 injuries and 11 deaths, and reports rose from 16 in the previous 12 months to 42 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
- 609
- Deaths reported
- 11
- Injuries reported
- 114
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 609 adverse event reports that list this exact device (DI 05705244006416), received between Oct 30, 2017 and Sep 15, 2026 — classified as 11 deaths, 114 injuries, 484 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (442 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 Component442
- Material Twisted/Bent75
- Adverse Event Without Identified Device or Use Problem27
- Loss of or Failure to Bond17
- Infusion or Flow Problem13
- Premature Separation11
- Connection Problem10
- Leak/Splash9
Patient problems
- No Known Impact Or Consequence To Patient295
- Hyperglycemia118
- Elevated Ketones/ Diabetic Ketoacidosis107
- No Clinical Signs, Symptoms or Conditions81
- Hypoglycemia9
- Coma5
- Death5
- Cramp(s) /Muscle Spasm(s)1
Recent adverse event reports
The 25 most recent of 609 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported that patient faced infusion set leak at site event om 18-Jan-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767659 ↗InjurySep 5, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50630946 ↗InjurySep 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50630914 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454054 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6)2026 and was treated with correction via the bolus option.
Patient problems: Hyperglycemia
MAUDE report 50269855 ↗InjuryAug 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had high blood glucose level which was treated with pump on (b)(6)2026. The blood glucose level was high for more than four hours.
Patient problems: Hyperglycemia
MAUDE report 50186612 ↗InjuryAug 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had high blood glucose level which was treated with pump on (b)(6)2026. The blood glucose level was high for more than four hours.
Patient problems: Hyperglycemia
MAUDE report 50186608 ↗InjuryAug 5, 2026Device Handling Problem
The patient was using expired infusion set that led to insulin flow block alarm and had high blood glucose levels of 324 mg/dL and was treated by correction bolus via pump on (b)(6)2025.
Patient problems: Hyperglycemia
MAUDE report 50137581 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose level that led to hospitalization for two hours and addressed by Manual Injection event (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50131284 ↗MalfunctionAug 3, 2026Partial Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111285 ↗DeathJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25530192 ↗DeathJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2017.
Patient problems: Coma; Hyperglycemia
MAUDE report 25529870 ↗DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481637 ↗DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481227 ↗DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DECEASED DUE TO AN UNKNOWN REASON ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441897 ↗DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441881 ↗MalfunctionMay 28, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2026 WHERE TAPE NOT STICKING DUE TO PERSPIRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317784 ↗MalfunctionApr 24, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE ON (B)(6) 2026 AS THE INFUSION SET CANNULA WAS BENT. THE INFUSION SET HAS BEEN IN USE FOR TWO DAYS.
Patient problems: Pain
MAUDE report 24975644 ↗MalfunctionApr 22, 2026Failure to Fire
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PROBLEM WITH THE CANNULA, AS IT DID NOT DEPLOY PROPERLY AND AS A RESULT THE PATIENT WAS UNABLE TO USE IT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949971 ↗MalfunctionApr 22, 2026Failure to Fire
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PROBLEM WITH THE CANNULA, AS IT DID NOT DEPLOY PROPERLY AND AS A RESULT THE PATIENT WAS UNABLE TO USE IT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949969 ↗InjuryApr 20, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUE WITH INFUSION SET AS TAPE DID NOT STICK ON 23-MAR-2026. THE BLOOD GLUCOSE LEVEL WAS HIGH WHICH WAS TREATED WITH PUMP.
Patient problems: Hyperglycemia
MAUDE report 24927910 ↗InjuryApr 20, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUE WITH INFUSION SET AS TAPE DID NOT STICK ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH WHICH WAS TREATED WITH PUMP.
Patient problems: Hyperglycemia
MAUDE report 24927813 ↗MalfunctionApr 15, 2026Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883056 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED HIGH BG TREATED BY CORRECTIONS WITH HER PUMP .
Patient problems: Hyperglycemia
MAUDE report 24882796 ↗MalfunctionApr 11, 2026Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE NOT STICKING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850971 ↗
Other Set, Administration, Intravascular devices
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- 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.
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