Mio® MMT-941600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244007338), received between Jul 4, 2018 and Mar 8, 2021 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2021Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT HER SON (APPROXIMATELY (B)(6) YEARS OF AGE) FELT VERY AGITATED BECAUSE OF HIGH BLOOD GLUCOSE LEVEL. MOREOVER, HE WAS GETTING INSULIN FLOW BLOCK SINCE OVER A MONTH, RANDOM TIMES AND NOTICED LEAKS UNDER THE SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441142 ↗
• MalfunctionOct 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED BY THE PATIENT THAT WHEN THE INFUSION SET WAS UNWOUND FROM THE SERTER DEVICE, THE TUBING CAME COMPLETELY DETACHED. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE GLUE WAS MISSING ON THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10625005 ↗
• InjuryApr 15, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT HER SON EXPERIENCED NAUSEA, VOMITING AND HIGH BLOOD GLUCOSE LEVEL (33.3 MMOL/L) AS THE PATIENT'S SITE WAS CHANGED THE NIGHT BEFORE AND THE CANNULA WAS NOT IN THE BODY. THEREFORE, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND SUBSEQUENTLY, IN THE MORNING OF (B)(6) 2020 AT 06:30 AM WITH BLOOD GLUCOSE LEVEL OF 33.3 MMOL/L. MOREOVER, PATIENT HAD KETONES. FURTHER, THEY REMOVED THE CANNULA AT THE HOSPITAL AND FOUND THAT THE CANNULA WAS BENT, BUT NOT IN HIM. THE CANNULA WAS INSERTED ON BUTT AND HE DID NOT FEEL ANY LEAKS. PATIENT'S MOTHER STATED THAT ONE INFUSION SET THEY INSERTED AFTER THE HOSPITAL, WAS ALSO BENT, THE THIRD ONE WAS CAUSING BLOOD GLUCOSE LEVEL TO RAISE BUT SHE CONTINUED TO BOLUS. PATIENT'S MOTHER REMOVED IT ON THE SECOND DAY, AND IT WAS SLIGHTLY BENT. THEY HAD BEEN USING SOLELY HIS UPPER BUTTOCKS FOR INSERTION, BUT DUE TO THE INCIDENT, PATIENT'S MOTHER AGREED TO USE ALTERNATE SITES FOR THE FORESEEABLE FUTURE. ALTHOUGH, PATIENT'S BLOOD GLUCOSE LEVEL REMAINED HIGHER THAN NORMAL FOR SEVERAL DAYS. DURING HOSPITALIZATION, HE RECEIVED INSULIN AND INTRAVENOUS MEDICATION (DRUG NAM

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9961705 ↗
• MalfunctionFeb 15, 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 WHEN THE TUBING CONNECTS TO THE CONNECTOR PART IT GOES WRONG EACH TIME. IN THE MORNING OF THE DAY OF THIS REPORT, SHE WAS HIGH AS WELL BECAUSE THE TUBING CAME OFF AGAIN, AND SHE ALREADY CHANGED HER WHOLE INFUSION SET. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 26 MMOL/L AND HAD SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE INFUSION WAS LAST CHANGED 2 DAYS AGO, AND NO LEAKAGE WAS OBSERVED EXCEPT IN THE DETACHED PART. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 26 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8342469 ↗
• DeathJul 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4). (B)(6). A WIDOW REPORTS TO MEDTRONIC HELPLINE THAT HER HUSBAND PASSED AWAY ON (B)(6) 2018 AFTER BEING ADMITTED TO HOSPITAL ON (B)(6) 2018 WITH DIABETIC KETOACIDOSIS (DKA). REPORTEDLY, PHYSICIANS STATE CAUSE OF DEATH AS SEVERE DKA. IT IS REPORTED THAT BLOOD GLUCOSE (BG) HAD BEEN HIGH FOR THE PREVIOUS COUPLE OF DAYS. A ROOMMATE INFORMED THAT THE PUMP WAS CONSTANTLY ALARMING SO THE PATIENT THEREFORE REMOVED THE PUMP. IT IS REPORTED THAT THE PATIENT FOR 3-4 DAYS PERFORMED MULTIPLE DAILY (SITE/SET) CHANGES. NO FURTHER INFORMATION IS AVAILABLE OR EXPECTED.

  Patient problems: Death; Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 7662262 ↗