Minimed™ Mio™ MMT-975A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05705244020429), received between Jun 11, 2021 and Jun 13, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET TUBING DETACHED EVENT ON (B)(6) 2024 AT CANNULA CONNECTION. THE INSERTION SITE WAS THE ABDOMEN. INFUSION SET WAS USED FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204542 ↗
• InjuryApr 5, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). FOREIGN: (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (21.8 MG/DL) AND IT STARTED TODAY AROUND 01:30 AM AFTER CHANGING THE INFUSION SET LAST NIGHT. THEY TRIED TO TREAT THE HIGH BLOOD GLUCOSE ISSUE WITH MANUAL INJECTION. THE PATIENT TESTED POSITIVE FOR KETONES (1.5 MMOL/L). MOREOVER, HE FACED A BENT CANNULA. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 21.8 MG/DL. 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 14011002 ↗
• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, IT WAS REPORTED THAT THE INFUSION SET'S TUBING WAS NO LONGER CONNECTED ON THE OTHER END CLOSE TO THE SITE LOCATION. THEREFORE, HER BLOOD GLUCOSE LEVEL WAS 18.8 MMOL/L AT THE TIME OF THIS EVENT. MOREOVER, THE INFUSION HAD BEEN USED TWO DAYS PRIOR OF THIS EVENT. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 9.6 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691432 ↗
• MalfunctionMar 3, 2022Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON'S INFUSION SET LEAKED AT THE SITE AFTER USING IT FOR ONE DAY AND THIS ISSUE OCCURRED WITH TEN INFUSION SETS FROM TWO BOXES. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE INFUSION SET TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657557 ↗
• MalfunctionOct 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, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART AT THE SITE CONNECTOR WHILE THE PATIENT WAS PULLING IT TO INSERT. THE SITE LOCATION WAS AT THE PATIENT'S ABDOMEN AND THE PUMP WAS HOOKED ON THE PANTS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12596969 ↗
• MalfunctionSep 1, 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, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART FROM THE QUICK RELEASE. THEREFORE, THE PATIENT'S HIGHEST BLOOD GLUCOSE LEVEL WAS 20 MMOL/L. THE SITE LOCATION WAS PATIENT'S ABDOMEN OR ARM, AND THE PUMP WAS CLIPPED ON HER BRA OR PANTS. MOREOVER, THE INFUSION HAD BEEN USED FOR FEW HOURS OR A DAY FOR SOME OF THEM. REPORTEDLY, THE INFUSIONS WERE STORED IN THE MEDICINE CABINET. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405966 ↗
• MalfunctionJul 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT REPORTED THE INFUSION SET'S TUBING DETACHED CLOSE TO THE SITE LOCATION. THIS ISSUE OCCURRED WITH FOUR SETS. THE SITE LOCATION WAS THE PATIENT'S BUTTOCKS. THE INFUSION HAD BEEN USED FOR A DAY OR LESS. HE KEPT HIS SUPPLY IN A DRAWER IN THE WASHROOM. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 12106195 ↗
• MalfunctionJun 11, 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 REPORTED THAT THE INFUSION SET'S TUBING GOT DETACHED AROUND THE QUICK RELEASE WHILE SHE WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S BUTTOCK AND THE PUMP WAS LOCATED IN FRONT OF HER BODY, CLIPPED ON HER BRA. MOREOVER, THE INFUSION HAD BEEN USED FOR TWO DAYS (SINCE (B)(6) 2021. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11981536 ↗