Minimed™ Quick-set™ MMT-397A (UDI 05705244017580)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
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05705244017580), received between Jun 3, 2024 and Sep 30, 2026 — classified as 17 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (8 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
- Adverse Event Without Identified Device or Use Problem8
- Material Twisted/Bent8
- Loss of or Failure to Bond6
- Premature Separation6
- Appropriate Device Problem Term/Code Not Available5
- Complete Blockage1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Hyperglycemia22
- No Clinical Signs, Symptoms or Conditions6
- Elevated Ketones/ Diabetic Ketoacidosis2
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 320 mg/dL. The high blood glucose persisted for 3 to 4 hours and was treated with a manual insulin injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946497 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 350 mg/dL. The high blood glucose lasted 3 to 4 hours and was treated with a correction bolus via the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50942806 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928598 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928580 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928567 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hyperglycemia event which was treated with an insulin Pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50915586 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose on (b)(6) 2026 which was treated by pump correction bolus and manual injection.
Patient problems: Hyperglycemia
MAUDE report 50913830 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced infusion set tape not sticking after one day of use event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912301 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced infusion set tape not sticking due to high heat event on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912251 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set fell off due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893788 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set came off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893686 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hyperglycemic episode on (b)(6) 2026,successfully managed with self-administered insulin via bolus which resulting in stable blood glucose levels with no reported complications.
Patient problems: Hyperglycemia
MAUDE report 50881766 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose levels which was corrected with bolus via pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877328 ↗InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50512869 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hypoglycemia
MAUDE report 50490824 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was hospitalized, admitted to the intensive care unit (ICU) due to ketoacidosis, hyperglycemia on (b)(6) 2026. The blood glucose level was 700 mg/dL at the time of event and the patient got treated with insulin injection. The patient tested positive for ketones.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50445886 ↗MalfunctionAug 16, 2026Fluid/Blood Leak
It was reported that the patient faced an event where leakage at the site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266223 ↗InjuryAug 11, 2026Leak/Splash
It was reported by the patient that there is Leakage at quick release area due which led high blood glucose and treated with correction bolus via Insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50212755 ↗InjuryAug 6, 2026Material Twisted/Bent
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50159247 ↗InjuryApr 11, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT INSULIN DID NOT EXIT AT THE QR WHICH IS AN INDICATION OF OCCLUSION .THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTION PUMP THERAPY. THE EVENT OCCURRED ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24851262 ↗InjuryApr 11, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT INSULIN DID NOT EXIT AT THE QR WHICH IS AN INDICATION OF OCCLUSION .THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTION PUMP THERAPY. THE EVENT OCCURRED ON (B)(6) 2026
Patient problems: Hyperglycemia
MAUDE report 24849674 ↗InjuryApr 11, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT INSULIN DID NOT EXIT AT THE QR WHICH IS AN INDICATION OF OCCLUSION .THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTION PUMP THERAPY. THE EVENT OCCURRED ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24849672 ↗InjuryApr 11, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT INSULIN DID NOT EXIT AT THE QUICK RELEASE WHICH IS AN INDICATION OF OCCLUSION. THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTION PUMP THERAPY. THE EVENT OCCURRED ON (B)(6) 2026
Patient problems: Hyperglycemia
MAUDE report 24849665 ↗InjuryApr 11, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT INSULIN DID NOT EXIT AT THE QR WHICH IS AN INDICATION OF OCCLUSION .THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTION PUMP THERAPY. THE EVENT OCCURRED ON (B)(6) 2026
Patient problems: Hyperglycemia
MAUDE report 24849662 ↗MalfunctionJun 3, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. THE PATIENT REPORTED THAT SHE FACED 05 INFUSION SET CANNULAS WERE BENT. SHE NOTICED THAT HER SITE WAS LEAKING AND THEN WHEN SHE PULLED OUT THE INFUSION SET AND FOUND THAT IT WAS BENT IN AN ANGLE ON(B)(6) 2024.THE INSERTION SITE OF THE INFUSION SITE WAS AT STOMACH . THE BLOOD GLUCOSE LEVELS OF PATIENT WAS ALSO VERY HIGH THAT SHE VOMITED. SHE WAS ABLE TO BRING HER BLOOD GLUCOSE LEVELS DOWN BY USING INSULIN PENS. THE PATIENT'S BLOOD GLUCOSE LEVEL AT TIME OF INCIDENT WAS 26 MMOL/L. PATIENT'S CURRENT BLOOD GLUCOSE LEVEL VALUE (AT TIME OF CALL) WAS 5 MMOL/L. THE LENGTH OF TIME INFUSION SET HAS BEEN IN USE WAS LESS THAN A DAY. UNOMEDICAL 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: Hyperglycemia
MAUDE report 19446766 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.