Minimed™ Quick-set™ MMT-396ATRecalls & 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
All models of MiniMed Infusion Sets (58) · Minimed Quick-set (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05705244024960), received between Aug 26, 2024 and Sep 23, 2026 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
- Complete Blockage2
- Infusion or Flow Problem2
- Loss of or Failure to Bond2
- Premature Separation2
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Hyperglycemia4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 230 mg/dl high for one to two hours and the patient was treated with insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50865644 ↗InjuryAug 21, 2026Material Twisted/Bent; Device Handling Problem
It was reported that patient does not have sufficient subcutaneous tissue which led to bent cannula while insertion of infusion set and experienced hyperglycemia (blood glucose was 300) treated with pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50362382 ↗MalfunctionAug 7, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170968 ↗InjuryAug 6, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50158085 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151729 ↗InjuryApr 15, 2026Complete Blockage; Material Twisted/Bent
IT WAS REPORTED ON 16-MAR-2026 THAT THE INFUSION SET CANNULA WAS BENT, WHICH ELEVATED THE GLUCOSE LEVEL TO 285 MG/DL AND WAS TREATED WITH A CORRECTION BOLUS VIA PUMP.
Patient problems: Hyperglycemia
MAUDE report 24887886 ↗MalfunctionApr 4, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT FACED THAT TAPE NOT STICKING EVENT ON 05-MARCH-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784735 ↗MalfunctionJul 4, 2025Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401718 ↗MalfunctionNov 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 02-NOV-2024. THE INSULIN EXITED FROM THE TUBING GREATER THAN NORMAL RESISTANCE WITH PLUNGER PUSH. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805206 ↗MalfunctionAug 26, 2024Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. ON 11-JUL-2024, REPORTED THAT PATIENT FACED INFUSION SET CRIMPED. INSERTION SITE WAS BELOW THE BELT LINE. INFUSION SET HAS BEEN USED FOR 2 DAYS. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20072785 ↗
Other Set, Administration, Intravascular devices
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- 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 14, 2026 · each report above links to its original FDA record
- 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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