Mio® MMT-965600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244007819), received between Aug 26, 2019 and Nov 14, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• InjuryNov 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON 13-OCT DUE TO HIGH BLOOD GLUCISE LEVEL AND REPORTED ISSUE WITH THE PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 20682539 ↗
• MalfunctionJul 6, 2022Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER WAS NOT ABLE TO USE THE PUMP FOR THREE DAYS DUE TO INSULIN FLOW BLOCKED ALARM. THIS ISSUE STARTED THREE DAYS AGO, SINCE THEN THE PATIENT HAS BEEN USING NEEDLES TO MANAGE HER BLOOD GLUCOSE LEVELS. MOREOVER, SHE CHANGED THE INFUSION SET AND RESERVOIR FOUR TIMES, BUT STILL FACED THE SAME ISSUE. REPORTEDLY, THE PATIENT WAS WAITING TO SEE HER HEALTHCARE PROFESSIONAL. SHE RECEIVED THE ALARMS DURING BASAL. AT THE TIME OF THE REPORT, HER BLOOD GLUCOSE LEVEL WAS 29 MMOL/L, AND THE PATIENT WAS VOMITING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 14927367 ↗
• InjuryMay 16, 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 LEVEL OF 30 MMOL/L. THEREFORE, IN THE MID-DAY OF (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. AT THE HOSPITAL, THE PATIENT REMOVED THE INFUSION SET AND NOTICED THAT CANNULA WAS BENT ON THE FIRST DAY OF USE. REPORTEDLY, THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN USED OVERNIGHT. MOREOVER, THE PATIENT HAD OCCLUSION AND THE PUMP DID NOT ALARM WITH INSULIN FLOW BLOCK. ON (B)(6) 2021, THE PATIENT WAS RELEASED FROM THE HOSPITAL. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 7.2 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 11830261 ↗
• MalfunctionOct 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE, WHILE THE PATIENT WAS UNCOILING THE TUBING TO INSERT. REPORTEDLY, AS HE UNCOILED THE INFUSION SET, IT WAS NOTICED THAT IT WAS NOT CONNECTED TO THE CANNULA AND IT WAS ALL STICKY. THE PATIENT'S SERUM GLUCOSE LEVEL WAS 13.9. THE INFUSIONS WERE STORED WERE STORED IN A CLOSET IN THE BEDROOM, AT A COOL DRY PLACE, AT ROOM TEMPERATURE. FURTHER, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION OF RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9236713 ↗
• InjuryAug 26, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, ABDOMINAL PAIN, HAD DIFFICULTY IN BREATHING AND WAS TESTED POSITIVE FOR KETONES. THE PATIENT ALSO HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 28 MMOL/L AT THE TIME OF INCIDENT. ON (B)(6) 2019, SHE WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. WHEN HER INFUSION SET WAS REMOVED, IT WAS FOUND THAT THERE WAS A LITTLE CURVE IN THE CANNULA. THE HOSPITAL TOLD THE PATIENT THAT THERE WERE MORE ISSUES THAN THE SLIGHTLY BENT CANNULA. ON (B)(6) 2019, SHE HAD COMPUTED TOMOGRAPHY SCAN AND WAS STILL IN THE HOSPITAL. 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 8929257 ↗