Minimed™ Mio™ MMT-923ARecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05705244019928), received between Sep 1, 2020 and Aug 3, 2026 — classified as 1 death, 11 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (19 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Fluid/Blood Leak

  It was reported that patient experienced high blood glucose and leakage at infusion site on (b)(6) 2023.

  Patient problems: Hyperglycemia

  MAUDE report 50112778 ↗
• MalfunctionMar 18, 2025Contamination; Contamination

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6)2024 WHERE THERE WAS A BALL OF PLASTIC ON THE END OF TIP OF CANNULA ALMOST LIKE CANNULA HAS BEEN SEALED. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 20.4 MMOL/L WHICH WAS TREATED BY CORRECTION BOLUS VIA PUMP AND MULTIPLE DAILY INJECTION. MOREOVER, THE SITE WAS PATIENT'S ABDOMEN AND ISSUE OCCURRED WITHIN THREE OR MORE HOURS AFTER INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 21629499 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULAS CRIMPED EVENTS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407385 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULAS CRIMPED EVENTS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407379 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULAS CRIMPED EVENTS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407357 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULAS CRIMPED EVENTS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407347 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULAS CRIMPED EVENTS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407338 ↗
• InjuryJan 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THAT THE PATIENT FACED DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2024 DUE TO INSULIN FLOW BLOCKED. LENGTH OF HOSPITALIZATION LESS THAN 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS 16.3 MMOL/L AND THE PATIENT WAS TREATED WITH CORRECTION VIA INJECTIONS. KETONES WERE REPORTED 0.1. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 21166496 ↗
• MalfunctionDec 11, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED ARAB EMIRATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6)2024. THE LEAKAGE WAS AT QUICK RELEASE. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20899988 ↗
• InjuryNov 26, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED ON (B)(6) 2024 DUE TO DIABETIC KETOACIDOSIS AND BENT CANNULA EVENT. BLOOD GLUCOSE AT THE TIME OF EVENT WAS 450 MG/DL.THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS ALSO FOUND POSITIVE FOR MODERATE KETONES. PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS (IV) DRIP. COMPANY 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 WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 20784292 ↗
• MalfunctionSep 27, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NEW ZEALAND. ON 28-AUG-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA CRIMPED ISSUE . THE SITE OF INSERTION WAS TUMMY . INFUSION SET HAS BEEN IN USE FOR 2 DAYS. COMPANY 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: Hyperglycemia

  MAUDE report 20319889 ↗
• MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CANNULA ISSUE WITH AN INFUSION SET. THE CANNULA WAS KINKED. THE EVENT OCCURRED ON (B)(6) 2024. COMPANY 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 WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20253950 ↗
• MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON 05-AUG-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS CROCKED, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO 270 MG/DL, THEREFORE PATIENT HAD RECEIVED MANUAL CORRECTION THROUGH PUMP INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20253867 ↗
• MalfunctionAug 10, 2024Leak/Splash; Leak/Splash

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 19956991 ↗
• MalfunctionJul 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED THAT THE INFUSION SET HAD OCCLUSION THAT PREVENTS THE FLOW OF INSULIN, WHICH CAUSE THE PATIENT BLOOD GLUCOSE ELEVATED TO 378 MG/DL. THE PATIENT ALSO HAD SYMPTOMS OF VOMITING NAUSEOUS AND THIRST. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19772070 ↗
• MalfunctionJul 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4), EVENT OCCURRED IN AUSTRALIA ON 05-JUNE-2024, IT WAS REPORTED BY THE PATIENT THAT HE RECEIVES AN INSULIN FLOW BLOCK ALARM. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685818 ↗
• MalfunctionJul 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN NEW ZEALAND IT WAS REPORTED THAT PATIENT FACED INFUSION SET OCCLUSION EVENT ON 06-FEB-2024. INSULIN DOES NOT EXIST WITH PLUNGER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644275 ↗
• MalfunctionJun 23, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA KINKED EVENT ON 23-MAY-2024. EVENT OCCURRED WITHIN TWO HOURS OF INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591363 ↗
• MalfunctionMay 26, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399113 ↗
• MalfunctionMay 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE FRANCE. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH INFUSION SET TAPE WAS NOT STICKING. PATIENT HAD REPORTED THAT PRODUCT NOT ADHERING ENOUGH LONG. PATIENT HAD TO CHANGE INFUSION SET EARLIER THAN THE SEVEN DAYS EXPECTED NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354245 ↗
• MalfunctionMay 16, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN EGYPT. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENT ON (B)(6) 2024 .THE EVENTS OCCURRED ON 2ND DAY AFTER INSERTION. THE INSERTION SITE WAS AT ABDOMEN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327995 ↗
• MalfunctionMay 12, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE MOTHER OF THE PATIENT THAT THE BG WENT UP TO 25 MMOL DUE TO BENT CANNULA. TREATMENT FOR HIGH BG IS BY BOLUS AND MANUAL INJECTION. PATIENT'S BG AT TIME OF INCIDENT WAS 25 MMOL/L AND CURRENT BG VALUE AT THE TIME OF CALL IS 15.1 MMOL/L. UNOMEDICAL DO NOT SEE BENT 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 WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19295546 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THE PATIENT'S INFUSION SET'S TUBING DETACHED CLOSE TO THE SITE LOCATION AFTER INSERTION. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN, AND THE PUMP WAS ON THE LEFT SIDE OF ABDOMEN. THE INFUSION SET HAD BEEN USED FOR ONE DAY. REPORTEDLY, 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. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 137 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228358 ↗
• MalfunctionMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT'S INFUSION SET'S TUBING WAS DETACHED NEAR QUICK RELEASE WHILE THE PATIENT WAS CHANGING CLOTHES. THE SITE LOCATION WAS LEFT SIDE OF PATIENT'S BUTTOCK, WITH THE PUMP LOCATED ON THE LEFT SIDE. MOREOVER, 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. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833947 ↗
• InjuryJan 3, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT FACED A BENT CANNULA WHEN SHE REMOVED THE INFUSION SETS. DUE TO THIS ISSUE SHE FELT SICK, VERY WEAK, HER BILE THREW UP AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THEREFORE, THEY TRIED TO TREAT IT VIA PUMP, BUT HER BLOOD GLUCOSE LEVEL WAS NOT COMING DOWN. SO, ON (B)(6) 2023, SHE WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE LEVEL OF 500 MG/DL. DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN DRIP INTRAVENOUSLY AS CORRECTIVE TREATMENT. AFTER STAYING FOR THREE DAYS IN THE HOSPITAL, THE PATIENT WAS RELEASED. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 114 MG/DL. 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 WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 18433836 ↗