Mio® MMT-945Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05705244007734), received between Jan 2, 2019 and Jul 21, 2024 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TAP NOT STICKING EVENT ON 19-SEP-2019. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19788897 ↗
• MalfunctionFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET TUBING SNAPPED 10 CM FROM THE TUBING CONNECTOR WHILE THE PATIENT WAS JUST LYING DOWN. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN AND THE PUMP WAS ON THE RIGHT SIDE. THE INFUSION HAD BEEN USED FOR AN HOUR AFTER INSERTION. MOREOVER, THE INFUSION SETS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11264147 ↗
• MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT SHE HAD AN INFUSION SET THAT GOT DETACHED WHILE SHE WAS SLEEPING, AND IT HAS NOW BECOME LOSE. REPORTEDLY, THE INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE SITE LOCATION WAS ON HER RIGHT SIDE OF ABDOMEN AND THE PUMP WAS LOCATED ON THE BELT ON THE RIGHT SIDE. THE INFUSION HAD BEEN USED FOR TWO DAYS. MOREOVER, THEY WERE UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10492737 ↗
• InjuryAug 10, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VOMITING AND HIGH BLOOD GLUCOSE LEVEL DUE TO BENT CANNULA. SHE FACED THIS ISSUE FOUR TIMES WITH HER INFUSION SETS. THEREFORE, SHE TRIED TO TREAT IT WITH CORRECTIVE BOLUS BUT HER BLOOD GLUCOSE LEVEL WENT SO HIGH (572 MG/DL) WHICH HAPPENED A DAY OR TWO, THAT ON (B)(6) 2020, AT 03:00 AM, SHE WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 572 MG/DL. THE PATIENT STAYED IN THE HOSPITAL FOR TWO NIGHTS. 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 10383983 ↗
• MalfunctionApr 3, 2020Detachment 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 HE NOTICED THAT AS HE HAD HIGH BLOOD GLUCOSE LEVELS, SO HE CHECKED THE INFUSION SET'S TUBING WHICH HAD DISCONNECTED FROM THE QUICK RELEASE WHILE SITTING. THE SITE LOCATION WAS ON THE LEFT SIDE OF HIS ABDOMEN AND THE PUMP WAS LOCATED ON THE LEFT SIDE. THE INFUSION SET WAS USED FOR ONE HOUR. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, THERE WAS NOT STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HIS BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9919525 ↗
• MalfunctionDec 11, 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 19-MAY-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE A VISUAL INSPECTION AND TEST FOR STATIC PULL WAS PERFORMED OF THE RETURNED USED DEVICE (1 USED SET) AND THE RESULT OF COMPLAINT INVESTIGATION 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 THE UNITED STATES. IT WAS REPORTED THAT ONE OF THE INFUSION SET'S TUBING WAS NOT CONNECTED TO THE NEEDLE. THE SITE OF INSERTION WAS THE PATIENT'S ABDOMEN AND THE BLOOD GLUCOSE LEVEL WAS 219 MG/DL AT THE TIME OF INCIDENT. NO FURTHER INFORMATION AVAILABLE. ON 19-MAY-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE A VISUAL INSPECTION AND TEST FOR STATIC PULL WAS PERFORMED OF THE RETURNED USED DEVICE (1 USED SET) AND THE RESULT OF COMPLAINT INVESTIGATION SHOWED THAT ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9449093 ↗
• MalfunctionAug 6, 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'S TUBING GOT LOOSE AND CAME APART FROM THE CANNULA PART DURING THE NIGHT. THE PATIENT WAS UNSURE IF THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET IN PLACE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8863681 ↗
• MalfunctionAug 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 DETACHED WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S BUTTOCK AND THE PUMP WAS WORN ON THE WAISTBAND. THE INFUSION WAS USED FOR 24 HOURS AND THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE IF THERE WAS ANY 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 8858658 ↗
• InjuryMay 10, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HE HAD CHANGED THE INFUSION SET AT NIGHT AND HE WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 569 MG/DL, AT THE TIME OF INCIDENT. IT TOOK FOUR HOURS TO GET HIM OUT OF BED. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS. A COUPLE OF DAYS LATER THEY TOOK OUT THE INFUSION SET AND NOTICED THE BENT CANNULA. THE INFUSION SET PART HAD GONE IN BUT BENT THE CANNULA AND THE PUMP HAD NOT ALARMED. HE WAS PUT ON AN INTRAVENOUS DRIP AS CORRECTIVE TREATMENT. THIS WAS THE SECOND TIME HE HAD EXPERIENCED A BENT CANNULA ISSUE. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN AND HE HAD A BIT OF AN ISSUE WITH SCARRED TISSUE, BUT HE ROTATED SITES. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS. 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 8598151 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HIS PREVIOUS INFUSION SETS WERE BENT DUE TO WHICH THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL, WHICH HE TRIED TO SELF-TREAT USING THE PUMP. SINCE HIS BLOOD GLUCOSE LEVEL WAS UNTREATABLE AND HE WAS FEELING EXTREMELY SICK, HE COULD NOT WAIT FOR A USUAL CAR RIDE. HE HAD TO BE TAKEN TO THE HOSPITAL IN AN AMBULANCE AS HE ENDED UP WITH DIABETIC KETOACIDOSIS. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL AT 648 MG/DL. THE HOSPITAL STAFF REMOVED HIS PUMP AND PUT HIM ON AN INSULIN DRIP FOR ABOUT TWO DAYS, WHICH BROUGHT DOWN HIS BLOOD GLUCOSE LEVEL. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS. REPORTEDLY, HE WEIGHED (B)(6) 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 8538727 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND BLOOD GLUCOSE LEVEL UPON ADMISSION WAS REPORTED TO BE 510 MG/DL. IN THE HOSPITAL, BLOOD GLUCOSE LEVEL LOWERED. 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 8534862 ↗
• InjuryApr 16, 2019Infusion or Flow Problem; Infusion or Flow Problem

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S FATHER REPORTED THAT THEY HAD ISSUES WITH A COUPLE OF INFUSION SETS AS THEY DID NOT DELIVER INSULIN. REPORTEDLY, HIS SON'S BLOOD GLUCOSE WAS 499 MG/DL AT THE TIME OF FIRST EVENT AND 522 MG/DL AT THE TIME OF SECOND EVENT. THEY STOPPED THE PUMP AND HE GAVE HIM A MANUAL INJECTION AND CHANGED THE SITE TWICE. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHEN HIS HIGH BLOOD GLUCOSE LEVEL WAS IN 500 MG/DL AND HE EXPERIENCED DIABETIC KETOACIDOSIS. MOREOVER, HIS STOMACH WAS HURTING WHICH DOUBLED UP THE PAIN. HE WAS ADMITTED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517108 ↗
• InjuryApr 7, 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 WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. HE REPORTED SOME INFUSIONS DID NOT HAD ADHESIVE, WERE NOT ADHERING AND KEPT FALLING OFF. THERE WAS NO GLUE ON THE SET AT ALL. IN THE MORNING OF THE DAY OF EVENT, HIS BLOOD GLUCOSE LEVEL WAS 887 MG/DL, HAD VOMITING AND HE WOKE UP, NOTICED IT WAS NOT STICKING. HE WAS HOSPITALIZED AND RECEIVED INSULIN DRIP VIA INTRAVENOUS ROUTE. ON THE DAY BEFORE THIS REPORT, HE TRIED TO GO BACK ON THE PUMP AND NOTICED THE OTHER SETS HAD NO ADHESIVE. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS. 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 8489941 ↗
• InjuryFeb 22, 2019Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE ALONG WITH NAUSEA AND WAS HOSPITALIZED. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 690 MG/DL AND AT THE TIME OF THIS REPORT WAS 127 MG/DL. THE PATIENT RECEIVED TREATMENT ORALLY IN THE HOSPITAL. THE INFUSION WAS LAST CHANGED A DAY BEFORE HOSPITALIZATION. THERE WERE LEAKS FOUND ON THE CONNECTOR SITE. REPORTEDLY, BEFORE HOSPITALIZATION, PATIENT WAS TREATED BY MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE. SINCE THREE DAYS PRIOR TO THIS REPORT, THE PATIENT HAD BEEN ADMITTED AND WAS STILL IN HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8361172 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. REPORTEDLY, THE PATIENT WAS IN A HURRY GETTING HER WHEEL CHAIR TO TOILET AND WHEN SHE PULLED DOWN THE PANTS TUBING CAME OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8221183 ↗
• MalfunctionJan 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT THE TUBING GOT DETACHED FROM THE BODY AND SITE LOCATION WAS LOWER ABDOMEN. THE LOCATION OF DETACHMENT WAS QUICK RELEASE. SHE WAS UNSURE WHETHER THE PUMP WAS LOCATED ON THE COUNTER OR ATTACHED TO HER PANTS. SHE WAS NOT ABLE TO USE THE INFUSION AS THE ISSUE OCCURRED RIGHT AWAY. 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 WASN'T DROPPED WITH THE SET CONNECTED TO THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211615 ↗
• InjuryJan 2, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S FATHER REPORTED, HIS SON BEGAN THROWING UP AND WAS ADVISED TO GO THE HOSPITAL. DUE TO HIGH GLUCOSE THE INFUSION SET WAS PULLED OUT AND CANNULA WAS FOUND TO BE BENT AND SITE LOCATION WAS UPPER HIP. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS. THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP AS A CORRECTIVE TREATMENT IN THE HOSPITAL. REPORTEDLY, INFUSION WAS IN USE FOR ONLY ONE DAY AND THE PATIENT HAD FOUR SETS WHICH WERE BENT. 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.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8207612 ↗