Minimed™ Quick-set™ MMT-387ARecalls & 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
Quick summary
This Minimed Quick-set infusion set is a single-use tube set for delivering medication under the skin. Many of its 395 adverse event reports describe the adhesive failing to bond or the set separating, and some describe leaks, bent tubing and high blood sugar. The reports list 102 injuries and no deaths, and no recalls name this device. Reports rose from 75 in the prior 12 months to 264 in the last 12 months.
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
- 468
- Deaths reported
- 0
- Injuries reported
- 142
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 468 adverse event reports that list this exact device (DI 05705244017672), received between May 7, 2021 and Sep 30, 2026 — classified as 142 injuries, 326 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (114 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
- Loss of or Failure to Bond114
- Premature Separation112
- Material Twisted/Bent84
- Adverse Event Without Identified Device or Use Problem58
- Leak/Splash56
- Infusion or Flow Problem41
- Complete Blockage29
- Detachment of Device or Device Component29
Patient problems
- No Clinical Signs, Symptoms or Conditions289
- Hyperglycemia119
- Elevated Ketones/ Diabetic Ketoacidosis46
- Hypoglycemia14
- Nausea7
- Hemorrhage/Blood Loss/Bleeding6
- Urinary Frequency / Polyuria3
- Vomiting3
Recent adverse event reports
The 25 most recent of 468 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949082 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948962 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929220 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced low blood glucose event on(b)(6)2026, which was managed with food intake
Patient problems: Hypoglycemia
MAUDE report 50915937 ↗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 Insulin from the pump.
Patient problems: Hyperglycemia
MAUDE report 50913847 ↗InjurySep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that the infusion set tape did not stick to skin upon insertion during sleep and therapy was interrupted as the patient experienced hyperglycemia event on (b)(6) 2026 and was treated Correction bolus via pump.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50897225 ↗InjurySep 25, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for one hour resulted in bent cannula and experienced Hyperglycemia on (b)(6)2026. The high blood glucose level was 449 mg/dl and treated with manual injection.
Patient problems: Hyperglycemia
MAUDE report 50894048 ↗InjurySep 25, 2026Device Handling Problem
It was reported that the patient experienced high blood glucose (440 mg/dL) on (b)(6) 2026 after changing the infusion set and reservoir but not following the Instructions for Use during the priming process. The event was treated with manual insulin injection.
Patient problems: Hyperglycemia
MAUDE report 50893673 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880470 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the patient experienced infusion set was leaking at the quick release event on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880363 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the patient experienced infusion set was leaking at the quick release event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880097 ↗InjurySep 24, 2026Leak/Splash
It was reported that the Patient had experienced Hyperglycemia associated with leakage at the site on (b)(6) 2026. The event was treated with bolus infusion.
Patient problems: Hyperglycemia
MAUDE report 50878886 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose event on (b)(6) 2026 and it was treated by manual bolus.
Patient problems: Hyperglycemia
MAUDE report 50877016 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 22.2 mmol/L high for more than hours and the patient was treated with Pump insulin + manual injection with insulin pen.
Patient problems: Hyperglycemia; Nausea
MAUDE report 50839658 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 22.2 mmol/L high for more than hours and the patient was treated with Pump insulin + manual injection with insulin pen.
Patient problems: Hyperglycemia; Nausea
MAUDE report 50839651 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 16 mmol/L high for more than four hours and the patient was treated with Pump insulin.
Patient problems: Hypoglycemia; Nausea
MAUDE report 50839641 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 22.2mmol high for more than four hours with symptoms of nausea and having to pee a lot, ammonia flavor in his mouth and tiredness and the patient was treated with Pump insulin + manual injection with insulin pen.
Patient problems: Hyperglycemia; Nausea; Urinary Frequency / Polyuria
MAUDE report 50839629 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 22.2mmol high for more than four hours with symptoms of nausea and having to pee a lot, ammonia flavor in his mouth and tiredness and the patient was treated with Pump insulin + manual injection with insulin pen.
Patient problems: Hyperglycemia; Nausea; Urinary Frequency / Polyuria
MAUDE report 50839623 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia on (b)(6) 2026. The blood glucose was 22.2mmol high for more than four hours with symptoms of nausea and having to pee a lot, ammonia flavor in his mouth and tiredness and the patient was treated with Pump insulin + manual injection with insulin pen.
Patient problems: Hyperglycemia; Nausea; Urinary Frequency / Polyuria
MAUDE report 50839620 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced elevated blood glucose levels event on (b)(6) 2026 and was treated with insulin pump. The patient also reported symptoms of nausea, tiredness and frequent peeing.
Patient problems: Fatigue; Hyperglycemia; Nausea
MAUDE report 50839306 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an high blood glucose level event on (b)(6) 2026 which was treated with 10 units of insulin.
Patient problems: Hyperglycemia
MAUDE report 50837804 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834498 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834202 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50824091 ↗InjurySep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50823928 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.