MiniMed™ Sure T™ MMT-862ARecalls & 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 Sure T (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a MiniMed SureT MMT-862A single-use infusion set, a small tube placed under the skin to deliver insulin. The 66 reports mostly describe the set coming loose or detaching, tubing that pulled or leaked, adhesive that stopped sticking, and torn packaging; some also mention blood sugar running high or low. There are 21 injuries and no deaths. 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
- 72
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05705244019263), received between Jan 29, 2020 and Sep 26, 2026 — classified as 22 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 Problem16
- Detachment of Device or Device Component13
- Loss of or Failure to Bond10
- Infusion or Flow Problem9
- Premature Separation7
- Leak/Splash6
- Tear, Rip or Hole in Device Packaging6
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Hyperglycemia16
- Hypoglycemia6
- Elevated Ketones/ Diabetic Ketoacidosis3
- Hemorrhage/Blood Loss/Bleeding1
- Loss of consciousness1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907706 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced infusion flow block along with high blood glucose which was addressed by insulin pen event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50866657 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793390 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791734 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791733 ↗MalfunctionSep 12, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745750 ↗InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50745610 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced a tape did not stick due to swimming event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467476 ↗MalfunctionAug 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50445210 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced low blood glucose event on (b)(6) 2026 while smart guard was updating, which was corrected by carbohydrate intake.
Patient problems: Hypoglycemia
MAUDE report 50269859 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
Patient had high blood glucose level and was treated with pump and manual syringe on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50266356 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
Patient reported low BG and got treated with carbs on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50266110 ↗MalfunctionAug 12, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220329 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It is reported that the patient had experienced high blood glucose levels which was addressed by correction bolus from pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50151001 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50108787 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose levels which was treated via insulin pump on (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50008862 ↗MalfunctionApr 23, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT FACED ADHESIVE ISSUE EVENT ON (B)(6) 2026. THE PATIENT REPORTED INFUSION SET TAPE NOT JUST FELL OFF DURING NAP TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24963909 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AND TREATED WITH BOLUS VIA PUMP ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24963588 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 AND WAS TREATED WITH PUMP INSULIN BOLUS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 24921748 ↗InjuryApr 16, 2026Device Handling Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED LOW BLOOD GLUCOSE EVENT ON 17-MAR-2026 AND SELF-MANAGED WITH CARBOHYDRATE INTAKE.
Patient problems: Hypoglycemia
MAUDE report 24893856 ↗InjuryApr 14, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCK ALARM EVENT (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS.
Patient problems: Hyperglycemia
MAUDE report 24869238 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EPISODE ON (B)(6) 2026, WHICH WAS SUCCESSFULLY MANAGED WITH SELF-ADMINISTERED MANUAL INJECTIONS, RESULTING IN STABLE BLOOD GLUCOSE LEVELS WITH NO REPORTED COMPLICATIONS.
Patient problems: Hyperglycemia
MAUDE report 24790784 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2026 AND WAS TREATED WITH CARBOHYDRATE INTAKE BY DRINKING COLA. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hypoglycemia
MAUDE report 24765315 ↗MalfunctionMar 31, 2026Detachment of Device or Device Component
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THE INFUSION SET TUBING CAME APART FROM QUICK RELEASE EVENT ON 17-JUL-2023. THE SITE LOCATION WAS THE LEFT ABDOMEN. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THE ACTIVITY LEADING UP TO THE EVENT WAS SLEEPING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24739229 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4). EVENT OCCURED IN GERMANY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2026 DUE TO LOW BLOOD GLUCOSE (17 MG/DL). THE PATIENT WAS UNCONSCIOUS DURING THE EVENT AND WAS TREATED WITH GLUCAGON. FOLLOWING STABILIZATION, INSULIN WAS ADMINISTERED VIA INFUSION. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hypoglycemia; Loss of consciousness
MAUDE report 24710050 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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