MiniMed™ Mio™ Advance MMT-213ARecalls & 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 Mio Advance (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MiniMed Mio Advance infusion set is a single-use set that delivers medication under the skin. Its 387 reports include 3 deaths and 68 injuries, and mostly describe the set failing to stay attached to the skin or separating, along with leaks. Some reports describe high or low blood sugar. Reports rose to 256 over the last year from 71 in the year before. No recalls name this device.
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
- 532
- Deaths reported
- 4
- Injuries reported
- 105
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 532 adverse event reports that list this exact device (DI 05705244019089), received between Aug 24, 2021 and Sep 30, 2026 — classified as 4 deaths, 105 injuries, 423 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (197 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond197
- Premature Separation188
- Adverse Event Without Identified Device or Use Problem74
- Detachment of Device or Device Component55
- Leak/Splash48
- Use of Incorrect Control/Treatment Settings45
- Fluid/Blood Leak44
- Infusion or Flow Problem22
Patient problems
- No Clinical Signs, Symptoms or Conditions371
- Hyperglycemia89
- Hypoglycemia35
- Elevated Ketones/ Diabetic Ketoacidosis26
- Hemorrhage/Blood Loss/Bleeding6
- Headache5
- Pain5
- Polydipsia3
Recent adverse event reports
The 25 most recent of 532 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 50951048 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off due to tape was not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951047 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949962 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pen and oral medication event on 30 Aug 2026.
Patient problems: Hyperglycemia
MAUDE report 50946767 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient face issue with infusion sets fell off as tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943145 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set came off on 01 Sep 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942179 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50929958 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927799 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916106 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916089 ↗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 injection on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50915592 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a high blood glucose level after changing the infusion set, and the issue was treated with an extra bolus using the pump on (b)(4) 2026.
Patient problems: Hyperglycemia
MAUDE report 50912545 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an infusion set tape not sticking event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912486 ↗MalfunctionSep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909903 ↗MalfunctionSep 26, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908260 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908239 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907150 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907142 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907120 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907108 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set tape not sticking event on (b)(6) 2026 due to sweat.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894070 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event reported passing out overnight and was later informed that a seizure may have occurred the patient reported multiple low glucose events prior to the incident on (b)(6)2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50893125 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event reported passing out overnight and was later informed that a seizure may have occurred the patient reported multiple low glucose events prior to the incident on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50893123 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set tape was not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883429 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883292 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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