Minimed™ Mio™ MMT-965ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244020139), received between Sep 24, 2020 and Aug 26, 2026 — classified as 1 injury, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: Hyperglycemia

  MAUDE report 50451538 ↗
• MalfunctionOct 23, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED AN INSULIN FLOW BLOCK ALARM ON (B)(6) 2024. DURING TROUBLESHOOTING INSULIN WAS NOT EXITED AND PUMP ALARMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513317 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED ISSUE OF INFUSION SET NEEDLE BREAK ON (B)(6) 2024. PATIENT HAD DIFFICULTY IN INSERTING THE INFUSION SET. THE SET WAS IN USE FOR LES THAN 1 DAY. THE INSERTION SITE WAS ABDOMEN. THE FRACTURE OCCURED DURING THE TIMEOF INSERTION AND THE NEEDLE WAS ALSO HARD TO REMOVE. THE BLOOD GLUCOSE LEVEL WAS 15MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19622116 ↗
• InjuryJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA, ON (B)(6) 2024 THE PATIENT EXPERIENCED ONE INFUSION KINKED CANNULA. THE TIME AND DATE OF HOSPITALIZATION IS (B)(6) AT 11PM . THE LENGTH OF HOSPITALIZATION IS 3 DAYS AND THE PATIENT WHEN ADMITTED TO HOSPITAL THE BLOOD GLUCOSE LEVEL WAS 36 MMOL/L AND THE REASON OF HOSPITALIZATION IS PATIENT FACING HIGH BLOOD GLUCOSE LEVEL AND DKA SEIZURE OR DIABETIC COMA AND HIGH BLOOD GLUCOSE DUE TO KINKED CANNULA. PATIENT ALSO GOT ISSUE OF KETONES LEVEL AND RESULTS OF KETONE LEVEL IS 3.4 NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19568334 ↗
• MalfunctionSep 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 24-NOV-2020: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE HEALTH EFFECT - IMPACT CODE AND COMPONENT CODE. MOREOVER, THE RESULT OF THE COMPLAINT INVESTIGATION (VISUAL INSPECTION) OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT'S INFUSION SET'S TUBING WAS FALLING OFF AND IT CAME APART AT THE INFUSION SITE WHILE SHE WAS SLEEPING, AS THE TUBING WAS TOO SHORT. THE SITE LOCATION WAS HER LEG AND THE PUMP WAS LOCATED IN THE RIGHT ARM ON HER SHIRT. MOREOVER, THE INFUSION HAD BEEN USED FOR 18 HOURS. THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY ((B)(6) 2020), HER BLOOD GLUCOSE LEVEL WAS 237 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10578878 ↗