Minimed™ Mio™ MMT-943ARecalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 05705244020016), received between Oct 9, 2020 and Aug 31, 2026 — classified as 1 death, 35 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (26 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518034 ↗
• InjuryAug 31, 2026Leak/Splash

  It was reported that the patient experienced leakage from the site which led to high blood glucose addressed by insulin pen, on (b)(6)2024.

  Patient problems: Hyperglycemia

  MAUDE report 50515318 ↗
• MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50512210 ↗
• InjuryAug 18, 2026Fluid/Blood Leak

  It was reported that patient experienced high blood glucose and treated with pen on (b)(6) 2024.

  Patient problems: Hyperglycemia

  MAUDE report 50294861 ↗
• InjuryAug 8, 2026Fluid/Blood Leak

  It was reported that the patient's infusion set was leaking at the site that lead to hyperglycemia event which was treated with insulin pump on (b)(6) 2025.

  Patient problems: Hyperglycemia

  MAUDE report 50187253 ↗
• InjuryAug 6, 2026Leak/Splash

  Patient problems: Hyperglycemia

  MAUDE report 50156427 ↗
• MalfunctionAug 3, 2026Premature Separation

  Patient problems: Skin Infection

  MAUDE report 50112235 ↗
• DeathJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DIED ON (B)(6) 2025 AND THE CAUSE OF THE DEATH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472118 ↗
• MalfunctionApr 21, 2026Failure to Fire

  IT WAS REPORTED THAT THE SERTER MECHANISM FAILED TO FUNCTION PROPERLY ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948563 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED HIGH BLOOD GLUCOSE LEVELS AND WAS TREATED WITH PUMP ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24752574 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SLOVAKIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2024. THE TUBING WAS DETACHED CLOSE TO SITE. THE INFUSION SET WAS IN USE FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712042 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE PATIENT REPORTED LEAKAGE DUE TO INFUSION SET CHANGE. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701741 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS INSERTED IN ABDOMEN AND WAS IN USE FOR FEW MINUTES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701457 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE SITE ON 18-SEP-2023, AFTER THE INFUSION SET HAD BEEN IN USE FOR 5 MINUTES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701333 ↗
• MalfunctionNov 19, 2025Device Handling Problem; Device Handling Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FORGOT TO REMOVE THE NEEDLE GUARD PRIOR TO INSERTION ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601310 ↗
• MalfunctionOct 30, 2025Infusion or Flow Problem; Infusion or Flow Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422130 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE A SMALL HOLE WAS FOUND IN THE TUBING ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK INSULIN PEN FOR THE TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 22465744 ↗
• InjuryJun 10, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM AND EVENTUALLY HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND OCCLUSION ALARM EVENT. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE EVENT. PATIENT GOT TREATED WITH INTRAVENOUS (IV) DRIP. PATIENT WAS ALSO FOUND POSITIVE FOR KETONES LEVEL. KETONES LEVEL WAS 2 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS FOR 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22173199 ↗
• InjuryMay 16, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT FACED A BENT CANNULA EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 395 MG/DL AND THE PATIENT HAD HIGH KETONES, WAS SICK AND UNWELL. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2025. THE PATIENT WAS TREATED BY MANUAL INJECTION AND PUMP. THE PATIENT STAYED IN HOSPITAL FOR LESS THAN TWENTY-FOUR HOURS. MOREOVER, THE INFUSION SET WAS USED FOR LESS THAN TWENTY-FOUR HOURS. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22034266 ↗
• MalfunctionMay 9, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF INFUSION SET LEAKAGE FROM THE CANNULA. HIGH BLOOD GLUCOSE RESULTING FROM THE EVENT WAS ADDRESSED USING CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 21993019 ↗
• MalfunctionMay 7, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF INSULIN FLOW BLOCKED ON (B)(6) 2025 LEADING TO HIGH BLOOD GLUCOSE (400MG/DL). THE SITE OF INSERTION WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 21974378 ↗
• MalfunctionMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. ON (B)(6) 2025, THE PATIENT HAD LOW BLOOD SUGAR OF 60 MG/DL. THEY ATE CARBS TO HELP, BUT STILL NEEDED MEDICAL HELP. THEY WENT TO THE EMERGENCY ROOM. THE PATIENT WAS USING AN INSULIN PUMP BEFORE THIS HAPPENED. THEY STAYED IN THE HOSPITAL FOR LESS THAN A DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 21959170 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF HIGH BLOOD GLUCOSE ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 30 MMOL/L AND HIGH KETONES OF 4.6MMOL/L. ALSO, THE PATIENT WAS WEAK, VOMITING, AND NAUSEATED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR MORE THAN TWENTY-FOUR HOURS DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE PATIENT WAS TREATED IN HOSPITAL BY INSULIN DRIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Nausea; Vomiting

  MAUDE report 21941680 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF INSULIN FLOW BLOCKED ON (B)(6) 2025. TROUBLESHOOTING CONFIRMED BLOCKAGE IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924480 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) ON THE EVENING OF (B)(6) 2025, DUE TO HIGH BLOOD GLUCOSE (BG). THE HOSPITAL STAY LASTED ONE DAY. THE BLOOD GLUCOSE LEVELS WERE ABOVE 600 MG/DL. PATIENT REPORTED SYMPTOMS OF DIZZINESS AND FREQUENT URINATION. PATIENT HAD KETONES OF +2. TREATMENT WAS GIVEN VIA MANUAL INSULIN INJECTIONS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 21916979 ↗