Minimed™ Mio™ MMT-923A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244020245), received between Apr 20, 2021 and Jun 13, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN ADHESIVE EVENT WITH AN INFUSION SET AS THE INFUSION SET AND THE SENSOR FELL OFF AFTER BEING USED FOR 1 DAY. PATIENT CONFIRMED TO NOT PERSPIRE HEAVILY AND WAS UNSURE OF THE CAUSE OF THE PRODUCT NOT ADHERING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526833 ↗
• MalfunctionMay 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 18/MAR/2024 AND 09/APR/2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INSULIN FLOW BLOCKED AFTER 5-10 SECONDS WHICH LED TO HIGH BLOOD GLUCOSE LEVEL OF 18.5 MMOL/L. THE PATIENT'S CURRENT BLOOD GLUCOSE VALUE (AT TIME OF CALL) WAS 18.5 MMOL/L. THE PATIENT RECEIVED BOLUS AS CORRECTIVE TREATMENT. THE INFUSION SET LAST CHANGED 2 DAYS AGO PRIOR TO THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19294855 ↗
• MalfunctionMay 12, 2022Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER CHILD'S INFUSION SET FELL OFF AND LEAKED AT THE SNAP CAP. THEREFORE, THIS ISSUE OCCURRED WITH SIX INFUSION SETS. THE SITE WAS PATIENT'S ABDOMEN/UPPER THIGH WHERE IT WAS INSERTED. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 6.7 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14386071 ↗
• MalfunctionDec 31, 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) 2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART AT THE SITE LOCATION WHILE THE PATIENT WAS SLEEPING/GOING TO THE BATHROOM A DAY AFTER THE INSERTION. THE SITE LOCATION WAS LEFT AND RIGHT SIDE OF PATIENT'S ABDOMEN. THE PUMP WAS SOMETIMES LOCATED ON THE SAME SIDE OR ON THE OPPOSITE SIDE IN RELATION TO THE SITE. REPORTEDLY, THE INFUSIONS WERE STORED AT HOME. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13123334 ↗
• InjuryOct 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT RECEIVED INSULIN FLOW BLOCK. THE BLOOD GLUCOSE LEVEL WAS REPORTED AS 7.4 MMOL/L AND THE INFUSION SET HAD BEEN USED FOR FEW HOURS. REPORTEDLY, THE SITE OF INSERTION WAS THE PATIENT'S ARM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 12679515 ↗
• MalfunctionAug 6, 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) 2021, THE PATIENT REPORT THAT TWO OF HER INFUSION SET'S TUBING DETACHED WHERE IT CONNECTS WHILE SLEEPING. THE SITE LOCATION WAS HER ABDOMEN, AND THE PUMP WAS LOCATED ON HER BELT WHILE SLEEPING. MOREOVER, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, 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 12286416 ↗
• InjuryApr 20, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6)2021, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT FACED A BENT CANNULA. THEREFORE, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED, WHERE SHE RECEIVED INSULIN DRIP INTRAVENOUSLY AS CORRECTIVE TREATMENT. REPORTEDLY, THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION HAD BEEN USED FOR TWO DAYS. THE PATIENT WAS HOSPITALIZED OVERNIGHT. 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 11691986 ↗