Minimed™ Mio™ MMT-921ARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05705244019898), received between Aug 10, 2020 and Jul 27, 2026 — classified as 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Partial Blockage; Material Twisted/Bent

  It was reported that the patient had high blood glucose because of crimped cannula and treated with IV infusion on (b)(6) 2023.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 50031773 ↗
• InjuryMar 26, 2026Device Handling Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH INSULIN BOLUS. THE PATIENT WAS USED EXPIRED PRODUCT LEADS TO BENT CANNULA. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24695543 ↗
• InjuryMar 24, 2026Device Handling Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIA EVENT ON (B)(6) 2026, WITH LEVELS REMAINING ELEVATED FOR MORE THAN FOUR HOURS AS THE PATIENT HAD BEEN USING AN EXPIRED INFUSION SET, WHICH LED TO AN INSULIN FLOW BLOCKED ALARM AND THE EVENT WAS TREATED WITH INSULIN BOLUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24674001 ↗
• InjurySep 10, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED DUE TO HYPOGLYCEMIA ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS 50 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH SHOTS BY PARAMEDIC AND INTRAVENOUS (IV) DRIP. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 23012651 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WITH 5 INFUSION SETS AS THE ADHESIVE DOES NOT STICK WELL AND COMES OFF AND DOES NOT LAST THE 3 DAYS THAT IT SHOULD. THE SITE WAS REPORTED TO BE STOMACH AND BUTTOCKS. THE REPORTER DOES NOT KNOW/ARE UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526817 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WITH 5 INFUSION SETS AS THE ADHESIVE DOES NOT STICK WELL AND COMES OFF AND DOES NOT LAST THE 3 DAYS THAT IT SHOULD. THE SITE WAS REPORTED TO BE STOMACH AND BUTTOCKS. THE REPORTER DOES NOT KNOW/ARE UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526816 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WITH 5 INFUSION SETS AS THE ADHESIVE DOES NOT STICK WELL AND COMES OFF AND DOES NOT LAST THE 3 DAYS THAT IT SHOULD. THE SITE WAS REPORTED TO BE STOMACH AND BUTTOCKS. THE REPORTER DOES NOT KNOW/ARE UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526815 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WITH 5 INFUSION SETS AS THE ADHESIVE DOES NOT STICK WELL AND COMES OFF AND DOES NOT LAST THE 3 DAYS THAT IT SHOULD. THE SITE WAS REPORTED TO BE STOMACH AND BUTTOCKS. THE REPORTER DOES NOT KNOW/ARE UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526812 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WITH 5 INFUSION SETS AS THE ADHESIVE DOES NOT STICK WELL AND COMES OFF AND DOES NOT LAST THE 3 DAYS THAT IT SHOULD. THE SITE WAS REPORTED TO BE STOMACH AND BUTTOCKS. THE REPORTER DOES NOT KNOW/ARE UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526811 ↗
• MalfunctionMay 19, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING CONSECUTIVE HIGH BLOOD GLUCOSE (BG) LEVELS SINCE LAST NIGHT AND THIS ISSUE CONTINUES TO PERSIST. THE PATIENT HAD CHANGED THE SET FOR THEIR INSULIN PUMP FOUR TIMES SINCE LAST NIGHT. ADDITIONALLY, THE PUMP HAD TRIGGERED AN INSULIN FLOW BLOCKAGE. THE PATIENT'S BG LEVEL AT THE TIME OF THE INCIDENT WAS MEASURED AT 22 MMOL/L. TO ADDRESS THE HIGH BG LEVELS, THE PATIENT HAS BEEN MANUALLY INJECTING INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19348379 ↗
• MalfunctionMay 19, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING CONSECUTIVE HIGH BLOOD GLUCOSE (BG) LEVELS SINCE LAST NIGHT AND THIS ISSUE CONTINUES TO PERSIST. THE PATIENT HAD CHANGED THE SET FOR THEIR INSULIN PUMP FOUR TIMES SINCE LAST NIGHT. ADDITIONALLY, THE PUMP HAD TRIGGERED AN INSULIN FLOW BLOCKAGE. THE PATIENT'S BG LEVEL AT THE TIME OF THE INCIDENT WAS MEASURED AT 22 MMOL/L. TO ADDRESS THE HIGH BG LEVELS, THE PATIENT HAS BEEN MANUALLY INJECTING INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19348375 ↗
• MalfunctionMay 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING CONSECUTIVE HIGH BLOOD GLUCOSE (BG) LEVELS SINCE LAST NIGHT AND THIS ISSUE CONTINUES TO PERSIST. THE PATIENT HAD CHANGED THE SET FOR THEIR INSULIN PUMP FOUR TIMES SINCE LAST NIGHT. ADDITIONALLY, THE PUMP HAD TRIGGERED AN INSULIN FLOW BLOCKAGE. THE PATIENT'S BG LEVEL AT THE TIME OF THE INCIDENT WAS MEASURED AT 22 MMOL/L. TO ADDRESS THE HIGH BG LEVELS, THE PATIENT HAS BEEN MANUALLY INJECTING INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19348358 ↗
• MalfunctionMay 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING CONSECUTIVE HIGH BLOOD GLUCOSE (BG) LEVELS SINCE LAST NIGHT AND THIS ISSUE CONTINUES TO PERSIST. THE PATIENT HAD CHANGED THE SET FOR THEIR INSULIN PUMP FOUR TIMES SINCE LAST NIGHT. ADDITIONALLY, THE PUMP HAD TRIGGERED AN INSULIN FLOW BLOCKAGE. THE PATIENT'S BG LEVEL AT THE TIME OF THE INCIDENT WAS MEASURED AT 22 MMOL/L. TO ADDRESS THE HIGH BG LEVELS, THE PATIENT HAS BEEN MANUALLY INJECTING INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19348348 ↗
• MalfunctionMay 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE AUSTRALIA ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT'S FATHER THAT FACED AN ISSUE WITH THE PUMP. THE PUMP WAS DETECTED AN OCCLUSION THAT PREVENTS THE INSULIN FLOW AND INSULIN BLOCKED ALARM WAS NOTICED. THE PATIENT WAS DISCONNECTED THE SITE AND REMOVE RESERVOIR FROM PUMP. IN ORDER TO TROUBLESHOOT THE PATIENT WAS REQUESTED TO REMAINS DISCONNECTED AND MANUALLY PUSH INSULIN SLOWLY THROUGH TUBING WITH PLUNGER. THE ISSUE WAS OCCURRED DURING THERAPY. INSULIN EXITS THE TUBING WAS NOTICED. THE PATIENT WAS REQUESTED TO CHANGE THE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19295136 ↗
• InjuryOct 27, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT FACED A BAD SITE LAST WEEK AND HAD TO USE EXTRA SETS TO MAKE SURE IT WAS WORKING RIGHT. EARLIER, THIS WEEK, THE PATIENT EXPERIENCED 2 BENT CANNULAS DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, FELT SICK/UNWELL, DEHYDRATED AND VOMITING. THEREFORE, ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE LEVEL OF 412 MG/DL. MOREOVER, THE TEST FOR KETONES WAS CONFIRMED AND KETONES WERE PRESENT. THE INFUSION SET WAS CHANGED ON THE MORNING OF HOSPITALIZATION. FURTHER, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT DURING WHICH THE INFUSION SETS WERE CHANGED 4 TIMES. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT. THE PATIENT SPENT THREE DAYS 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 INFORMA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 15678438 ↗
• InjuryMay 8, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S PARENT REPORTED THAT THEIR DAUGHTER HAD HIGH BLOOD GLUCOSE LEVELS FOR THREE DAYS NOW, DUE TO A BENT CANNULA WHICH THEY TRIED TO TREAT WITH A PUMP AND MANUAL INJECTION. THE INFUSION SET WAS CHANGED ON (B)(6) 2022. AT THE TIME OF THE EVENT ((B)(6) 2022), HER BLOOD GLUCOSE LEVEL WAS 20 MMOL/L. CONSEQUENTLY, ON (B)(6) 2022 AT 1:00 AM, SHE WAS ADMITTED TO THE HOSPITAL AS SHE EXPERIENCED VOMITING, ABDOMINAL PAIN, AND POSITIVE RESULTS IN KETONES TEST (3 MMOL/L). SHE WAS ADMITTED IN THE HOSPITAL FOR THREE DAYS. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 26 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 14332609 ↗
• MalfunctionMay 5, 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, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER HAD LEAKING ON THE INFUSION SET'S TUBING AND CONNECTOR IN ALL EIGHT INFUSION SETS. SHE GOT THEM LAST MONTH WHICH SHE STARTED USING TWO WEEKS AGO. ONE TIME HER DAUGHTER TOLD HER THAT HER PANTS WERE WET BECAUSE OF THE LEAKAGE AND THE PUMP SMELLS INSULIN. THIS ISSUE OCCURRED BECAUSE THE INFUSION SET'S TUBING CAME APART AT THE CONNECTOR DURING INSERTION. REPORTEDLY, THE INFUSION HAD BEEN USED FOR TWO DAYS. THE SITE LOCATION WAS PATIENT'S BELLY AND THIGH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14285681 ↗
• MalfunctionJan 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). ON (B)(6) 2020, IT WAS REPORTED THAT, WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET'S TUBING WAS DISCONNECTED FROM THE SITE AT THE QUICK RELEASE AND HAD HIGH BLOOD GLUCOSE LEVEL. THE SITE LOCATION WAS PATIENT'S LEFT LEG AND THE PUMP WAS LOCATED ON THE LEFT SIDE. MOREOVER, THE INFUSION HAD BEEN USED FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE STORED IN A PLASTIC BOX UNDERNEATH THE BATHROOM SINK. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 302 MG/DL. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11241452 ↗
• InjuryAug 10, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT INFUSION SET (CANNULA) AND A BENT SENSOR. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 50 MMOL/L. THEREFORE, THE PATIENT TRIED TO TREAT IT WITH SUBCUTANEOUS INSULIN DELIVERY WITH PUMP. SUBSEQUENTLY, ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS. THE PATIENT WAS ADMINISTERED AN INSULIN DRIP AS CORRECTIVE TREATMENT. THE PATIENT WAS HOSPITALIZED 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 10384073 ↗