Mio® MMT-943600Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05705244007512), received between Feb 28, 2019 and Aug 20, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was hospitalized for seven days due to high blood glucose on (b)(6) 2026 and was addressed by intravenous insulin drip.

  Patient problems: Hyperglycemia

  MAUDE report 50344839 ↗
• MalfunctionMar 30, 2026Leak/Splash

  THIS EMDR IS BEING SUBMITTED FOR UNKNOWN NUMBER QUANTITY. REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAK WITH MULTIPLE INFUSION SET ON (B)(6) 2023.THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709444 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAK WITH MULTIPLE INFUSION SET ON (B)(6) 2023.THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709428 ↗
• InjuryMar 30, 2021Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT REPORTED THAT SHE WAS PREGNANT AND HAS NOTICED THAT NINE OF THE INFUSION SETS SHE USED LEAKED ON THE SITE. THE INFUSION SET HAD BEEN USED FOR ONE DAY (FEW HOURS). MOREOVER, THERE WAS NO STRESS OR PULL ON THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587920 ↗
• MalfunctionFeb 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED, AS IT WAS ACCIDENTALLY PULLED UPON INSTALLATION AND THE CONNECTION PART CAME OFF. UPON VISUAL INSPECTION PERFORMED ON THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR, MISSING GLUE IN THE CONNECTION AND WAS NOTICED EXCESS OF GLUE ON THE CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336281 ↗
• MalfunctionDec 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT ON (B)(6) 2020, HER SON'S INFUSION SET'S TUBING DETACHED AT THE TUBING CONNECTOR WHILE HER SON WENT IN THE POOL FOR SWIMMING. THIS ISSUE OCCURRED WITH THREE INFUSION SETS. THE SITE LOCATION WAS PATIENT'S LEFT ABDOMEN AND LOWER BACK. MOREOVER, THE PATIENT WAS NOT DISCONNECTED TO THE PUMP. THE INFUSION HAD BEEN IN USE SINCE (B)(6) 2020. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT'S MOTHER 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10939511 ↗
• MalfunctionOct 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, THE PATIENT'S MOTHER REPORTED THAT ON SUNDAY NIGHT HER SON'S INFUSION SET'S TUBING HAD DETACHED AT THE SITE WHILE THE PATIENT WAS SLEEPING. THE NEXT MORNING (ON MONDAY), HE WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL OF 25 MMOL/L. THE SITE LOCATION WAS PATIENT'S SIDE, AND THE PUMP WAS CLIPPED TO HIS PANTS. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE AND HALF DAYS. 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 AS PATIENT IS ACTIVE IN SLEEP AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10640497 ↗
• MalfunctionSep 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, THE PATIENT'S MOTHER REPORTED THAT ON SUNDAY NIGHT HER SON'S INFUSION SET'S TUBING HAD DETACHED AT THE SITE WHILE THE PATIENT WAS SLEEPING. THE NEXT MORNING (ON MONDAY), HE WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL OF 25 MMOL/L. THE SITE LOCATION WAS PATIENT'S SIDE AND THE PUMP WAS CLIPPED TO HIS PANTS. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE AND HALF DAYS. 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 AS PATIENT IS ACTIVE IN SLEEP 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: Hyperglycemia

  MAUDE report 10578398 ↗
• MalfunctionFeb 19, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ON 06-NOV-2020: FOLLOW UP INFORMATION WAS SUBMITTED FOR UPDATING HEALTH EFFECT - CLINICAL CODE AND RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING) SHOWED THAT THE TUBING WAS DAMAGED (CUT). BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING DETACHED CLOSE TO THE SITE LOCATION WHEN HE SUSPENDED THE PUMP, AND WENT TO HAVE HIS SHOWER, REATTACHED AND WAS LAYING ON HIS BED. THE SITE LOCATION WAS PATIENT'S UPPER LEFT HIP AND THE PUMP WAS LOCATED ON THE SAME SIDE IN RELATION TO THE SITE. MOREOVER, THE INFUSION HAD BEEN IN USE FOR TWO DAYS. 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9725582 ↗
• MalfunctionJan 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HER INFUSION SET'S TUBING CAME OUT OF THE QUICK RELEASE COMPLETELY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9630778 ↗
• MalfunctionOct 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME OUT OF THE QUICK RELEASE COMPLETELY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9254228 ↗
• MalfunctionApr 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE LAST INFUSION SET FROM THE BOX WAS DEFECTIVE AS THE TUBING WAS DETACHED FROM THE SITE THAT WAS STICKING ONTO THE BODY. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR AND EXCESS OF GLUE WAS NOTICED WHERE TUBING WAS JOINED ON THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8511997 ↗
• MalfunctionApr 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING COMPLETELY DISCONNECTED FROM THE BLUE PORTION ON THE QUICK RELEASE AND FROM THE SITE PORTION. THE PATIENT CHANGED OUT THE TUBING PORTION AND EVERYTHING WAS STILL WORKING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8486356 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT SHE HAD INSERTED ONE INFUSION SET AND THE HOSE WAS NOT CONNECTED TO THE CLIP. REPORTEDLY, THE TUBING WAS HANGING FROM THE SITE. MOREOVER, SHE STATED THAT WHEN SHE GOT UP FROM THE CHAIR, IT HAD NOT PULLED, IT WAS JUST HANGING. HER INFUSION SET'S TUBING CAME APART FROM THE QUICK RELEASE AND HAD NOT ATTACHED BACK. THE SITE LOCATION WAS RIGHT SIDE ABOVE HER WAIST TOWARD HER ABDOMEN AND THE PUMP ON THE SAME SIDE OF INSERTION SITE AND WAS CLIPPED TO HER WAISTBAND. THE INFUSION WAS USED FOR 20 MINUTES AND DID A DOSE FOR SUPPER. THE INFUSIONS WERE STORED IN LINEN CLOSET IN THE HALL. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. ON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE) AND A DROP OF GLUE WAS FOUND ON THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8377265 ↗