Minimed™ Quick-set™ MMT-396A (UDI 05705244018068)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
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
- 18
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05705244018068), received between Sep 1, 2026 and Sep 30, 2026 — classified as 14 injuries, 4 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
- Adverse Event Without Identified Device or Use Problem10
- Material Twisted/Bent4
- Complete Blockage2
- Appropriate Device Problem Term/Code Not Available1
- Leak/Splash1
- Loose or Intermittent Connection1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Hyperglycemia14
- No Clinical Signs, Symptoms or Conditions4
- Pain1
- Skin Infection1
Recent adverse event reports
The 18 most recent of 18 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 300 mg/dL. The high blood glucose persisted for 3 to 4 hours and was treated using the insulin pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50946265 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 380 mg/dL for greater than 4 hours. The event was treated with manual insulin injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946089 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 380 mg/dL. The high blood glucose persisted for greater than 4 hours and was treated with manual insulin injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946082 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932018 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932013 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928590 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced skin infection and pain at the site of insertion due to hyperglycemia (260 mg/dl) event on (b)(6) 2026 and was treated with Correction bolus via pump.
Patient problems: Hyperglycemia; Pain; Skin Infection
MAUDE report 50928573 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hyperglycemia event which was treated with a Manual bolus on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50915587 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910021 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with Pen on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50893293 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with Pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50893269 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with Pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50893261 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with Pump on 25 Aug 2026.
Patient problems: Hyperglycemia
MAUDE report 50893229 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with Pump on(b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50893193 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the patient experienced an infusion set leaking at the site event during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878608 ↗MalfunctionSep 23, 2026Loose or Intermittent Connection
It was reported that patient experienced infusion set leak at the quick release due to quick release was not tightly connected event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866887 ↗MalfunctionSep 7, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652826 ↗InjurySep 1, 2026Complete Blockage; Material Twisted/Bent
The patient reported experiencing infusion set bent cannula after insertion event on (b)(6)V2026 which disrupted insulin delivery and resulted in hyperglycemia, the elevated blood glucose was successfully managed by the patient through self-administration of insulin via multiple daily injections, resolving the issue with no further complications.
Patient problems: Hyperglycemia
MAUDE report 50547795 ↗
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- 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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