Minimed™ Quick-set™ MMT-386A (UDI 05705244017825)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244017825), received between Jun 27, 2024 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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 Problem1
- Leak/Splash1
Patient problems
- Hyperglycemia2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 Pen on(b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50915590 ↗MalfunctionJun 27, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL 265 MG/DL, THEREFORE, PATIENT DID A BOLUS THROUGH THE PUMP AND INSULIN LEAKED WHILE DOING THE BOLUS LEAKED FROM SITE SET WAS DUE TO SET CHANGED BLOOD GLUCOSE STAYED HIGH ENTIRE DAY YESTERDAY BLOOD GLUCOSE WAS AT 250 MG/DL BEFORE BEDTIME. THE HIGH BLOOD GLUCOSE WAS CORRECTED THROUGH THE PUMP. NOW, SENSOR GLUCOSE LEVEL WAS 177 MG/DL. ALSO, BEFORE CONNECTING BACK TO SET, PATIENT ALWAYS COMPLETE REWIND/LOAD RESERVOIR PROCESS AND INSULIN EXIT AS WELL. THE INFUSION SET WAS USED FOR THREE DAYS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 19622999 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.