Mio® MMT-925Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05705244007871), received between Jan 15, 2019 and Aug 25, 2020 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, THE PARENT OF THE PATIENT REPORTED THAT AS THEIR DAUGHTER WOKE UP THIS MORNING, IT WAS NOTICED THAT THE INFUSION SET'S TUBING WAS DISCONNECTED FROM THE CLIP AT THE QUICK RELEASE, WHILE SHE WAS SLEEPING. REPORTEDLY, THE TUBING WAS STILL CONNECTED TO THE PUMP AND THE END LOOKED LIKE A BIG BALL OF GLUE. THE SITE LOCATION WAS HER STOMACH AND THE PUMP WAS PROBABLY IN PANTS OR SHORTS. THE INFUSION SET WAS USED FOR A DAY AND THEY WERE STORED IN A PLASTIC SHELF CONTAINER. THEY WERE UNSURE OF ANY STRESS OR PULL ON THE TUBING, BUT THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HER BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10447234 ↗
• MalfunctionJul 31, 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 THAT THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT NOTICED INSULIN OUT OF THE TUBING TWO HOURS AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH THREE INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10348500 ↗
• MalfunctionJul 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 30-JUN-2020, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD COME OFF AT THE SITE PORTION (SITE LOCATION). SHE HAD TWO MORE INFUSION SETS THAT MESSED UP IN THE LAST TWO DAYS. AT THE TIME OF THIS REPORT, SHE WAS GOING FOR HER THIRD INFUSION SET. FURTHER, SHE HAD INSERTED IT IN HER LEG, SHE HAD ONE YESTERDAY AND NOW TODAY WITH THE SAME BEHAVIOR. THE PUMP WAS LOCATED ON THE SAME SIDE IN RELATION TO THE SITE AND THE INFUSION HAD BEEN IN USE FOR FEW HOURS. 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 PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10256466 ↗
• MalfunctionMay 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04-SEP-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE). BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE INFUSION SET'S TUBING WAS DETACHED FROM PATIENT'S BODY AT THE SITE LOCATION WHILE SLEEPING AND HER BLOOD GLUCOSE LEVEL WENT HIGH TO 350 MG/DL. THE SITE LOCATION WAS PATIENT'S BACK AND THE PUMP WAS IN HER BED. MOREOVER, THE INFUSION SET WAS USED FOR NOT LESS THAN 24 HOURS. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. REPORTEDLY, HER CURRENT (NEW) INFUSION SET WAS WORKING FINE SO FAR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10090601 ↗
• InjuryFeb 27, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE FELT SICK, HAD VOMITING, LOST CONSCIOUSNESS AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AS SHE FACED A BENT CANNULA. FURTHER, AT THE TIME OF THIS EVENT THE PATIENT WAS PREGNANT, AND HER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL, WHICH SHE TRIED TO TREAT WITH A PUMP. CONSEQUENTLY, ON (B)(6) 2019 AT 07:00 PM, SHE WAS ADMITTED TO THE HOSPITAL AS HER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION HAD BEEN IN USE FOR THE FIRST DAY. DURING HOSPITALIZATION, SHE RECEIVED INSULIN DRIP VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. 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 9760773 ↗
• MalfunctionNov 5, 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'S TUBING HAD DETACHED UPON INSERTION. THE SITE LOCATION WAS ON THE RIGHT SIDE OF UPPER PART OF ABDOMEN AND THE PUMP WAS IN THE RIGHT-SIDE 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 9277073 ↗
• MalfunctionMay 3, 2019Detachment 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 04-FEB-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICES (5 USED SETS) SHOWED THAT ALL TEST RESULTS WERE WITHIN SPECIFICATIONS BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S SON REPORTED THAT THE PATIENT HAD FIVE SETS WHERE THE TUBING DETACHED CLOSE TO THE SITE LOCATION AND WOULD JUST BE HANGING WHILE THE PATIENT WAS EITHER WALKING, SITTING OR SLEEPING. SHE HAD A BAD KNEE, SO SHE DID NOT ENGAGE IN STRENUOUS ACTIVITIES. THE SITE LOCATION WAS EITHER LEFT OR RIGHT HIP AND THE PUMP WAS EITHER ON THE LEFT, RIGHT OR SAME SIDE AS THE INFUSION SET IN THE BRA OR POCKET. THIS HAPPENED USUALLY ON THE FIRST OR SECOND DAY OF USE. 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 8576672 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ISSUES WITH THREE INFUSION SETS IN THE FORM OF BENT CANNULAS. SHE WOKE UP AND HER BLOOD GLUCOSE WAS 132 MG/DL, WENT THROUGH HER NORMAL ROUTINE AND TOOK HER SET OFF AND SHOWERED. AS SHE CHANGED HER SET, IT WAS NOTICED THAT THE CANNULA WAS FOLDED OVER ON ITSELF. SHE PUT ON A NEW SET AND BY THE TIME OF BREAKFAST HER BLOOD GLUCOSE LEVEL WAS ELEVATED TO 287 MG/DL. SHE SELF-TREATED WITH THE BOLUS BY THE PUMP AND GAVE HERSELF AN INJECTION WITH A SYRINGE. SHE STATED THROUGHOUT THE DAY HER BLOOD GLUCOSE LEVELS CONTINUED TO ELEVATE. SHE HAD VOMITING, HER BLOOD GLUCOSE WAS IN THE RANGE OF 400 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS. SHE WAS TAKEN TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED, AFTER SOME INVESTIGATIONS. WHEN THE SET WAS REMOVED, AFTER BEING ADMITTED, SHE NOTICED THE BENT CANNULA. SHE ENDED UP IN THE HOSPITAL WITH THE LAST BENT CANNULA. DURING HOSPITALIZATION, SHE WAS ON INSULIN DRIP. THE LOCATION WAS LEFT LOWER SIDE OF STOMACH. THE INFUSION SET WAS USED FOR THE FIRST DAY. CURRENTLY, HER BLOOD GLUCOSE WAS 132 MG/DL AND SHE WAS ADMITTED FOR THREE DAYS. EARLIER AT THE TIME OF F

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517260 ↗
• InjuryApr 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ADHESIVE SET ISSUES WITH FOUR SETS AS ALL OF THEM DID NOT STICK TO HER BODY. THE PATIENT USUALLY INSERTED THEM IN HER LEG. REPORTEDLY, HER BLOOD GLUCOSE RAISED AFTER A TRIP TO THE BEACH AND SO SHE DID A BOLUS AND THEN WENT TO BED. LATER, SHE NOTICED THAT HER BLOOD GLUCOSE WAS OVER 600 MG/DL WHICH SHE SELF-TREATED WITH THE PUMP AND THEN AN HOUR LATER AGAIN, HER BLOOD GLUCOSE LEVEL REMAINED THE SAME WHICH SHE TREATED MANUALLY WITH A SHOT. SUBSEQUENTLY, HER BLOOD GLUCOSE DID NOT COME DOWN AND SHE TOOK ANOTHER SHOT AND ANOTHER AND THEN HER BLOOD GLUCOSE LEVEL CAME TO 243 MG/DL, BUT SHE BECAME UNCONSCIOUS. THE EMERGENCY MEDICAL SERVICES WERE CALLED AS HER BLOOD PRESSURE WENT LOW AT THAT TIME AND THEY TRANSPORTED HER AND NOTICED AFTER TESTING AN INFECTION. SHE ALSO EXPERIENCED DIABETIC KETOACIDOSIS. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL IN THE INTENSIVE CARE UNIT AND WAS TREATED FOR HER HIGH BLOOD GLUCOSE LEVELS AND THE INFECTION, ALSO INVESTIGATIONS WERE STILL BEING PERFORMED ON HER. THE PATIENT WAS HOSPITALIZED SINCE FOUR DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517167 ↗
• 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 REPORTED THAT THE NIGHT BEFORE THIS REPORT, PATIENT'S DOG PAWS GOT CAUGHT IN THE TUBING, AND IT SNAPPED. THE PATIENT WAS NOT WEARING THE SET AND HER BLOOD GLUCOSE LEVEL WAS 110-120 MG/DL. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS STRESS OR PULL ON THE TUBING AS THE DOG'S PAWS PULLED ON IT 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 8468019 ↗
• MalfunctionMar 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT NEEDLE DETACHED FROM THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467942 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN SHE WOKE UP, THE INFUSION SET TUBING HAD DETACHED NEAR THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S HIP. THE PUMP WAS WORN NEXT TO HER ON THE SIDE OF THE BED AND 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: Hyperglycemia

  MAUDE report 8458829 ↗
• InjuryMar 19, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE WAS NOT RECEIVING INSULIN DUE TO A BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 900 MG/DL WHEN SHE WAS ADMITTED IN THE HOSPITAL. SHE STAYED IN THE ICU FOR A WEEK AND WAS TREATED WITH MANUAL INJECTIONS. 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 8431229 ↗
• MalfunctionFeb 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET TUBING HAD DETACHED DURING INSERTION AND IT FELL OUT OF THE INJECTOR. THE SITE LOCATION WAS PATIENT'S LEFT ABDOMEN. THE PUMP WAS WORN WHEN THE PATIENT WAS JUST TRYING TO INSERT THE INFUSION SET. THE INFUSION HAD BEEN IN USE ON THE FIRST DAY AND THE INFUSIONS WERE STORED IN A CLOSET. 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 8357074 ↗
• MalfunctionJan 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). THE PATIENT REPORTED INFUSION SET DETACHMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292151 ↗
• MalfunctionJan 15, 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 INFUSION SET TUBING CAME APART WHILE SLEEPING. THE SITE LOCATION WAS AT LEFT SIDE OF THE ABDOMEN. THE LOCATION OF DETACHMENT WAS AT SITE. THE INFUSION WAS BEING USED FOR 2 DAYS. REPORTEDLY, THE PUMP WAS LAYING ON THE PATIENT'S SIDE. THE INFUSIONS WERE NOT STORED OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS NOT SURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING, HOWEVER, THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. THE PATIENT ALSO STATED HER BLOOD GLUCOSE WAS HIGH DUE TO THIS DETACHMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8247437 ↗