Mio® MMT-921600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244007390), received between Mar 28, 2019 and Dec 5, 2022 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. (B)(6) 2022, IT WAS REPORTED THAT ON AN UNKNOWN DATE (IN THE YEAR 2019), THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE SITE WHILE WORKING AS THE NATURE OF HER JOB IS PHYSICAL AND IT PULLED OFF AT WORK. THE SITE LOCATION WAS PATIENT'S ABDOMEN, AND THE PUMP WAS WORN ON THE BRA. 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. THE PUMP WAS DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913209 ↗
• MalfunctionApr 6, 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 PATIENT'S INFUSION SET'S TUBING DETACHED FROM THE SITE. THEREFORE, HER BLOOD GLUCOSE LEVEL WAS 19 MMOL/L AT THE TIME OF THE INCIDENT. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 5.7 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 14019201 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON 16-NOV-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE AWARENESS DATE AND THE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT ALL THE TEST RESULTS WERE WITHIN SPECIFICATION. BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT 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 ON (B)(6) 2021, THE PATIENT'S INFUSION SET'S TUBING DETACHED FROM WHERE THE TUBING STARTS, WHEN SHE WAS GOING TO INSERT IT, BUT THEN INSERTED ANOTHER INFUSION SET. THE SITE LOCATION WAS HER LEG, AND THE PUMP WAS LOCATED ON HER HIP. THE INFUSIONS WERE STORED IN A CUPBOARD. THERE WAS NOT STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 13.6 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408639 ↗
• InjuryDec 2, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE MOTHER OF THE PATIENT REPORTED THAT HER DAUGHTER EXPERIENCED VOMITING, ABDOMINAL PAIN AND DIFFICULTY IN BREATHING. FURTHER, SHE HAD HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS FOR WHICH SHE WAS BROUGHT TO THE HOSPITAL. SUBSEQUENTLY, ON (B)(6) 2019, SHE WAS ADMITTED TO THE HOSPITAL, WITH BLOOD GLUCOSE LEVEL OF APPROXIMATELY 33.3 MMOL/L AND POSITIVE RESULTS AS 6.8 MMOL/L IN THE KETONES TEST DUE TO A BENT CANNULA WHICH WAS NOTICED UPON REMOVAL. DURING HOSPITALIZATION, SHE RECEIVED SYRINGES AND DRUG NAME UNKNOWN (INTRAVENOUSLY) FOR HYDRATION AS A CORRECTIVE TREATMENT. AT THE HOSPITAL THEY TREATED HER AND PUT HER BACK ON THE PUMP AND SHE GOT A BENT CANNULA AGAIN. MOREOVER, SHE WAS ON AN INJECTION AND THEY WILL SWITCH HER TO ANOTHER PUMP AS PER THE HEALTH CARE PROFESSIONAL'S RECOMMENDATION. THE INFUSION WAS LAST CHANGED IN THE MORNING OF THE SAME DAY AND SHE HAD TWO OF THE SITES WHICH WERE BENT. ON (B)(6) 2019, SHE WAS RELEASED FROM 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 CAN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9393541 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2019, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING HAD DETACHED FROM THE QUICK RELEASE WHILE SLEEPING LAST NIGHT. THE SITE OF LOCATION WAS HER HIP. THE INFUSION WAS USED FOR ONE DAY AND THEY WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. SHE STATED THAT THERE WAS STRESS OR PULL ON THE TUBING AS THE PUMP BECAME WRAPPED WHEN SHE MOVED. FURTHER, THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. THIS ISSUE HAPPENED TWICE. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9001026 ↗
• MalfunctionSep 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IN THE MORNING OF (B)(6) 2019, THE PATIENT NOTICED THAT THE INFUSION SET'S TUBING DETACHED FROM QUICK RELEASE WHILE SHE WAS SLEEPING. THE SITE OF LOCATION WAS HER STOMACH. SHE CHANGED THE INFUSION ON (B)(6) 2019. SHE WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8963958 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET TUBING HAD DETACHED FROM THE PLASTIC PART BEFORE INSERTION. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458832 ↗