Minimed™ Mio™ MMT-945A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05705244020368), received between Dec 8, 2021 and Nov 14, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. ON (B)(6)2024, PATIENT FACED INFUSION SET TUBING DETACHMENT. SITE OF INSERTION WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682512 ↗
• InjuryOct 8, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT. PATIENT WAS ADMITTED TO HOSPITAL DUE TO ANY BLOOD GLUCOSE VALUE, DIABETIC KETOACIDOSIS SEIZURE AND DIABETIC COMA. LENGTH OF HOSPITALIZATION WAS FOR TWO NIGHTS. DATE OF HOSPITALIZATION WAS (B)(6) 2024.THE BLOOD GLUCOSE LEVEL WAS AT TIME OF HOSPITALIZATION WAS 22.2 MMOL/L. NAUSEA, DEHYDRATION HEADACHES SYMPTOMS WERE REPORTED AT TIME OF HOSPITALIZATION. THEREFORE, PATIENT WAS TREATED WITH INTRAVENOUS. 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 20396552 ↗
• MalfunctionSep 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET OCCLUSION EVENT. THE BLOOD GLUCOSE WAS REPORTED 20 MMOL/L AND TREATED WITH BOLUS VIA PUMP. NO FURTHER INFORMATION.

  Patient problems: Hyperglycemia

  MAUDE report 20292576 ↗
• MalfunctionSep 12, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED ON (B)(6) 2024 THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA WAS KINKED WHICH RESULTS INTO HIGH BLOOD GLUCOSE LEVEL OF 27MMOL/L. DURATION OF INFUSION SET USED WAS WITHIN 48 HOURS. THE ISSUE GOT RESOLVED BY REPLACING THE INFUSION SET. 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: Hyperglycemia

  MAUDE report 20209121 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT INSERTED THE INFUSION SET ON (B)(6) 2023 AND IT CAME APART ON (B)(6) 2023 AT THE SITE CONNECTOR WHILE HE WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S TUMMY. THE INFUSION HAD BEEN USED FOR THREE DAYS. REPORTEDLY, THE PATIENT WAS UNSURE WHETHER THERE WAS STRESS OR PULL ON THE TUBING. FURTHER, THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. IN THE MORNING ((B)(6) 2023), HIS BLOOD GLUCOSE LEVEL WAS 11 MMOL/L. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036853 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT'S FATHER REPORTED THAT HIS SON HAD ANOTHER INSTANCE OF TUBING DETACHMENT LAST NIGHT WHILE SLEEPING. THE PUMP WAS IN A SOFT TOY WHICH HE CUDDLES. THE INFUSION SET HAD BEEN USED LESS THAN A DAY AND THEY ARE IN A CLOSED CUPBOARD IN HIS BEDROOM. FURTHER, THE PUMP WAS NOT DROPPED AND THERE WAS NO STRESS ON THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12959066 ↗