Minimed™ Quick-set™ MMT-398A (UDI 05705244017948)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
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244017948), received between Aug 8, 2026 and Sep 29, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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
- Loss of or Failure to Bond3
- Premature Separation3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Fluid/Blood Leak1
Patient problems
- Hyperglycemia3
- No Clinical Signs, Symptoms or Conditions3
- Elevated Ketones/ Diabetic Ketoacidosis1
- Fatigue1
- Polydipsia1
- Vomiting1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Fatigue; Polydipsia; Vomiting
MAUDE report 50929998 ↗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 50915578 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the tape not sticking due to sweat event on 27 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911883 ↗InjurySep 5, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50631616 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265557 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event of tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264172 ↗InjuryAug 8, 2026Fluid/Blood Leak
It was reported that the patient faced leakage at infusion set insertion site event which led to hyperglycemia (190 mg/dL) and was treated with insulin shots and insulin pump on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50186296 ↗
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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