Mio® MMT-921Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05705244007376), received between Dec 24, 2018 and Mar 13, 2020 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT EARLIER IN THE WEEK SHE HAD SOME ISSUES WITH HER INFUSION WHICH LED TO HIGH BLOOD GLUCOSE LEVELS, DIABETIC KETOACIDOSIS AND SHE WAS NOT ABLE TO WALK AT ONE POINT. SUBSEQUENTLY, AFTER TWO DAYS OF HIGH BLOOD GLUCOSE LEVELS HER HUSBAND TOOK HER TO THE EMERGENCY ROOM AFTER TRYING MANUAL INJECTIONS. AT THE TIME OF THE INCIDENT, HER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CONSEQUENTLY, ON (B)(6) 2020, SHE WAS ADMITTED IN THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS (OVER 600 MG/DL) AND DIABETIC KETOACIDOSIS BECAUSE OF A BENT CANNULA. DURING HOSPITALIZATION, SHE WAS UNSURE ABOUT THE TREATMENT RECEIVED, BUT SHE STATED THAT THEY TOOK OFF THE PUMP. SHE STAYED IN THE HOSPITAL FOR THREE DAYS AS PER REPORT DATED (B)(6) 2020. 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 9828244 ↗
• InjuryNov 26, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER HAD HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL (AT THE TIME OF INCIDENT), SO THEY WENT TO THE HEALTH CARE PROFESSIONAL AND WERE SUBSEQUENTLY SENT TO THE HOSPITAL. MOREOVER, THE PATIENT WAS STABLE NOW, AND THE MOTHER OF THE PATIENT AND THE HEALTH CARE PROFESSIONAL IDENTIFIED THAT THE BENT CANNULA WAS THE REASON OF HIGH BLOOD GLUCOSE LEVEL. IT WAS STATED THAT THE INFUSION SET WAS CHANGED TWICE. 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 9374572 ↗
• InjurySep 25, 2019Material Twisted/Bent; Material Twisted/Bent

  ON 13-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE SOFT CANNULA WAS FOUND TO BE BENT (AT THE TIP) AND THE PCC CONNECTOR NEEDLE WAS CLOGGED (BY INSULIN). BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT EVERY TIME SHE PUSHED HER INFUSION SET TO GO IN HER STOMACH, IT WAS CURVING AND WAS NOT GIVING HER INSULIN. MOREOVER, HER PUMP DID NOT ALARM FOR INSULIN FLOW BLOCKED. FURTHER, AS SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS, SO SHE WAS TREATED WITH MANUAL INJECTIONS AND REMOVED HER PUMP. IT WAS STATED THAT THE SITE LOCATION WAS HER ABDOMEN AND WHEN SHE PULLED OFF THE SITE, SHE NOTICED A BENT CANNULA. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. SUBSEQUENTLY, ON (B)(6) 2019, BEFORE 12:00 PM, SHE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVEL OF 600 MG/DL AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, SHE RECEIVED INSULIN DRIP VIA INTRAVENOUS ROUTE. REPORTEDLY, THE PATIENT HAD ENOUGH SUBCUTANEOUS TISSUE WHERE THE SET WAS INSERTED AND HAD ISSUES WITH SPOTS OF HARDENED TISSUES A

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9114536 ↗
• InjuryMay 31, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE ON THE FIRST DAY OF INFUSION SET USE DURING INSERTION DUE TO WHICH SHE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 450 MG/DL AT THE TIME OF INCIDENT. THE PATIENT TRIED TO SELF-TREAT IT WITH THE PUMP AND CHANGED THE INFUSION SET. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS, WHERE SHE RECEIVED UNSPECIFIED MEDICATION THROUGH INTRAVENOUS ROUTE. THE PATIENT RECONNECTED TO THE PUMP IN THE HOSPITAL. THE SITE LOCATION WAS PATIENT'S STOMACH. THE PATIENT STAYED IN THE HOSPITAL FOR TWO DAYS AND WAS STILL THERE WITH BLOOD GLUCOSE LEVEL AT 450 MG/DL AT THE TIME OF THIS REPORT. 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 8657000 ↗
• InjuryMay 3, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT FACED A BENT CANNULA ISSUE AND HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 30.8 MMOL/L AT THE TIME OF INCIDENT. THE PATIENT WENT TO THE EMERGENCY ROOM FOR SEVERE DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL (30 MMOL/L). THE PATIENT RECEIVED INSULIN AS CORRECTIVE TREATMENT IN THE HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND BLOOD GLUCOSE LEVEL WAS 11.3 MMOL/L AT THE TIME OF THIS REPORT. 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 8577149 ↗
• MalfunctionApr 6, 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 TUBING DETACHED. THE SITE LOCATION WAS PATIENT'S TUMMY AND THE PUMP WAS IN HER POCKET. 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 8489778 ↗
• MalfunctionMar 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE INFUSION SET DETACHED FROM THE PATIENT'S BODY RIGHT OUT OF THE SITE. THE SITE LOCATION WAS IN HER BOTTOM AND THE PUMP WAS LOCATED ON HER HIP. THE INFUSION WAS IN USE 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 THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467979 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET BROKE. REPORTEDLY, WHILE THE PATIENT OPENED IT AND TOOK THE TUBING OUT, IT CAME OFF AND THE PATIENT WAS NOT ABLE TO REATTACH IT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8459342 ↗
• MalfunctionDec 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE TUBING OF THE INFUSION SET DETACHED AT QUICK RELEASE. REPORTEDLY, IT WAS OBSERVED THAT THE INSULIN CAME OUT OF THE TUBING ABOUT 8-10 HOURS AFTER THE SET WAS CHANGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8193635 ↗