Minimed™ Mio™ MMT-965A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05705244020399), received between May 4, 2021 and Apr 10, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE ISSUES WITH INFUSION SET, WHICH FELL OFF AFTER 1-2 DAYS OF USE EVENT ON (B)(6) 2026 NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843244 ↗
• MalfunctionApr 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE ISSUES WITH INFUSION SET, WHICH FELL OFF AFTER 1-2 DAYS OF USE EVENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843155 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPERIENCED AN INFUSION SET LEAK WITHIN LESS THAN ONE HOUR OF USE, LOCATED AT THE SITE PORTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709432 ↗
• MalfunctionMay 18, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. ON 17 APR 2024, IT WAS REPORTED LEAKS ON THE INFUSION SET AND WERE CLOSE TO THE SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348271 ↗
• MalfunctionNov 8, 2023Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 27-OCT-2023, IT WAS REPORTED THAT A CHILD PATIENT'S INFUSION SET WAS CHANGED ON (B)(6) 2023, WITH BLOOD GLUCOSE LEVEL OF 33 MMOL/L AND THE NEXT DAY (B)(6) 2023, THE PATIENT FACED TWO INSULIN FLOW BLOCKED ALARM AT SCHOOL. THEREFORE, ON THE SAME DAY, AT 10 AM, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVEL (27 MMOL/L) WITH FEELING OF DIZZINESS AND NON-STOP VOMITING. THE PATIENT HAD HIGH KETONE LEVEL OF 5.9 MMOL/L. MOREOVER, THE SITE LOCATION WAS PATIENT'S ABDOMEN. THE PATIENT STAYED FOR ONE DAY IN THE HOSPITAL AND THE NEXT DAY, (B)(6) 2023 AT 12 PM, THE PATIENT WAS RELEASED FROM THE HOSPITAL. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 6.6 MMOL/L. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 18090506 ↗
• InjuryMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2023, THE PATIENTS MOTHER REPORTED THAT THIS MORNING, HER CHILD FACED AN ISSUE WITH THE INFUSION SET AS THE PLASTIC PIECE OF THE CANNULA CAME OUT AND THEY DID NOT NOTICE IT UNTIL THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (29 MMOL/L) WHICH THEY TRIED TO TREAT IT WITH PEN. THEY HAD TO HOLD IT WITH THE HAND TO PLACE THE CANNULA AND IT WAS HARD TO INSERT. PREVIOUSLY, ON MONDAY, THEY HAD LOST THREE INFUSION SETS. MOREOVER, THE SITE LOCATION WAS PATIENTS ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR ONE DAY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 16.2 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 16511040 ↗
• InjuryOct 19, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON FACED A BENT CANNULA DUE TO WHICH HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (33.3 MMOL/L) WITHIN THE LAST 2 WEEKS AND THIS ISSUE OCCURRED WITH FIVE INFUSION SETS. HER SON REPORTED THIS ISSUE TO HER 2-3 DAYS AGO. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND BUTTOCK. MOREOVER, THE INFUSION SETS HAVE BEEN USED FOR SAME DAY, FIRST DAY AND FOR SECOND DAY. UNOMEDICAL 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 15630429 ↗
• InjuryJul 14, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER RECEIVED AN INSULIN FLOW BLOCK ON (B)(6) 2022. HER DAUGHTER HAD HIGH BLOOD GLUCOSE LEVEL IN THE NIGHT, AND THEY CHANGED THE SITE FIVE TIMES, AS SHE FACED SOME BENT CANNULA AND AT OTHER EVENTS AND INSULIN FLOW BLOCK. AT THE TIME OF THE INCIDENT, HER BLOOD GLUCOSE LEVEL WAS 27.7 MMOL/L. REPORTEDLY, IT HAPPENED FOUR DAYS AGO, AND HER MOTHER STATED THAT SHE WAS CERTAIN IT WAS THE INFUSION SET CANNULA THAT WAS DEFECTIVE. MOREOVER, HER MOTHER HAD GIVEN NEEDLE AS THEY HAD NO TUBING AVAILABLE AND COULD NOT ORDER IT AS IT WAS CLOSED ON THE WEEKEND. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 6.7 MMOL/L. UNOMEDICAL 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 15011189 ↗
• InjuryMay 13, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). REPORT SOURCE FOREIGN: (B)(6). ON (B)(6) 2022, THE PATIENT'S FATHER REPORTED THAT THE PATIENT FACED A BENT CANNULA ISSUE WHILE SITTING. IN THE MORNING OF (B)(6) 2022, THE INFUSION SET WAS LAST CHANGED, AND THE HIGH BLOOD GLUCOSE EVENT ALSO OCCURRED THE SAME DAY. THE SITE LOCATION WAS THE PATIENT'S LOWER BACK AND THE INFUSION SET HAD BEEN USED FOR A FEW HOURS. AT THE TIME OF THE INCIDENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 36.6 MMOL/L. CONSEQUENTLY, IN THE MORNING OF (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HIGH BLOOD GLUCOSE LEVEL OF 36.6 MMOL/L, KETONES, AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT WAS ADMINISTERED SOME UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY. MOREOVER, THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 11 MMOL/L. UNOMEDICAL 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 14389464 ↗
• InjuryOct 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT'S FATHER REPORTED THAT HIS DAUGHTER RECEIVED INSULIN FLOW BLOCK THIS MORNING (3:00 AM). REPORTEDLY, SHE FELT WEAK, TIRED AND HAD HEADACHE. AT THE TIME OF INCIDENT, HER BLOOD GLUCOSE LEVEL WAS 16 MMOL/L AND KETONES WERE 1.5 MMOL/L, WHICH THEY CORRECTED MANUALLY WITH A NEEDLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679482 ↗
• InjuryOct 1, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. CONSEQUENTLY, ON (B)(6) 2021 AT 10:00 AM, THE PATIENT WAS TAKEN TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF MORE THAN 33 MMOL/L AND THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS DUE TO A BENT CANNULA. REPORTEDLY, THE BENT CANNULA WAS NOTICED AFTER REMOVAL OF THE INFUSION SET. THE PATIENT RECEIVED SOME UNSPECIFIED DRUG INTRAVENOUSLY (DRUG NAME UNKNOWN) AS CORRECTIVE TREATMENT AND STAYED THERE OVERNIGHT. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS STILL MORE THAN 33 MMOL/L. UNOMEDICAL 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 12559258 ↗
• MalfunctionAug 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 10-MAY-2021, IT WAS REPORTED THAT WHILE THE PATIENT WAS INSERTING A NEW SITE, SHE NOTICED AN INFUSION SET'S TUBING ANOMALY. SHE HAD ALREADY FILLED THE TUBING AND WHEN SHE TRIED TO CONNECT THE TUBING TO THE QUICK RELEASE, THE TUBING DETACHED. THEREFORE, SHE TOOK ANOTHER INFUSION SET FROM THE BOX AND USED IT. SITE WAS NOT YET INSERTED IN HER BODY WHEN THE INCIDENT OCCURRED. REPORTEDLY, THE INFUSIONS WERE STORED IN THE DRAWER. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. UPON INVESTIGATION ON THE RETURNED USED DEVICE (1 TUBING), MISSING GLUE WAS FOUND IN THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306092 ↗
• InjuryMay 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, THE PATIENT'S MOTHER REPORTED THAT HER SON EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (ONE MONTH AGO (B)(6) 2020 AND AGAIN YESTERDAY ON (B)(6) 2020 (17 MMOL/L). ON (B)(6) 2020, THE INFUSION SET WAS INSERTED. REPORTEDLY, THE INFUSION SETS DID NOT STICK (ADHESION PROBLEMS). AT THE TIME OF THE INCIDENT HIS BLOOD GLUCOSE LEVEL WAS 24 MMOL/L, WHICH THEY TREATED WITH THE NEEDLE. THE PATIENT'S MOTHER MENTIONED THAT SETS WERE STORED IN THE BATHROOM RATHER THAN IN KITCHEN TO TRY TO MAKE SURE AMBIENT TEMPERATURE IN ROOM WAS NOT TOO WARM. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 10 MMOL/L AND FELT GOOD. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11768298 ↗