Minimed™ Mio™ MMT-921A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244020214), received between Sep 23, 2021 and Oct 26, 2023 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 11-OCT-2023, IT WAS REPORTED BY PATIENT'S MOTHER THAT HER DAUGHTER FACED A BENT CANNULA DUE TO WHICH SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THEREFORE, ON (B)(6) 2023, SHE WENT TO EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL. DURING HOSPITALIZATION, THE PATIENT RECEIVED FLUIDS OF SALINE (UNKNOWN) AND INSULIN. CURRENTLY, THE PATIENT IS ON MULTIPLE DAILY INJECTIONS. 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 WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 18009774 ↗
• MalfunctionJan 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2022, IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THE SITE LOCATION WAS PATIENT'S LEFT THIGH AND THE PUMP WAS CLIPPED TO PATIENT'S UNDERWEAR. THE INFUSION HAD BEEN INSERTED ON SATURDAY. REPORTEDLY, THE INFUSIONS WERE STORED IN THE KITCHEN CUPBOARD. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. ACCORDING TO THE COMPLAINT INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 SET), 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 16222533 ↗
• MalfunctionDec 26, 2022Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2022, THE PATIENT REPORTED THAT SHE IS PREGNANT, AND HER INFUSION SET'S SITE WAS NOT STICKING. THEREFORE, THE INFUSION SET'S SITE WAS LEAKING, AND THE SITE LOCATION WAS PATIENT'S LOWER BACK. HER BLOOD GLUCOSE LEVEL WAS WITHIN RANGE. THIS ISSUE OCCURRED WITH EIGHT INFUSION SETS. MOREOVER, THE INFUSION SET HAD BEEN USED FOR FOUR DAYS. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16047294 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2022, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME APART AT THE TUBING CONNECTOR WHILE HE WAS INSERTING THE INFUSION SET. THE SITE LOCATION WAS PATIENT'S ABDOMEN, AND THE PUMP WAS LOCATED ON THE OTHER SIDE OF THE ABDOMEN. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. 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 SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400892 ↗
• MalfunctionSep 23, 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517765 ↗