Minimed™ Mio™ MMT-941ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05705244019980), received between May 10, 2024 and Oct 8, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT HE RECEIVE AN ALARM. IN TROUBLESHOOTING BLOCKAGE WAS FOUND IN THE TUBE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401130 ↗
• MalfunctionSep 26, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET LEAKS IN THE TUBING SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308644 ↗
• MalfunctionJul 21, 2024Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING BENT WITH WHITE MARKS EVENT ON 13-JUN-2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19788898 ↗
• MalfunctionJul 20, 2024Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THAT THE PATIENT FACED KINKED TUBING. THE SITE WAS PATIENT'S STOMACH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786622 ↗
• InjuryJul 14, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA ON 13-JUNE-2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET CANNULA WAS KINKED DUE TO WHICH HOSPITALIZATION OCCURS DUE TO HYPERGLYCEMIA AND HIGH KETONES. 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 19737512 ↗
• MalfunctionJul 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS OCCLUSION IN INFUSION SET WHICH PREVENTS THE FLOW OF INSULIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641563 ↗
• MalfunctionJun 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN EGYPT. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET TAPE NOT STICKING WITHIN TWO DAYS OF USE. INFUSION SET FELL OFF AT THE TIME OF SWIMMING. INFUSION SET WAS PLACED IN ABDOMEN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611729 ↗
• InjuryMay 22, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT HE WAS HOSPITALIZED FOR 7 HOURS DUE TO HYPERGLYCEMIA EPISODE AND HIGH KETONES. HE RECEIVED AN INFUSION FLOW BLOCK ALARM FROM TWO SETS. PATIENT ALSO REPORTING THAT HER PUMP IS NOT DELIVERING AUTO CORRECTION. HIGH BLOOD GLUCOSE LEVEL WAS 27 MMOL/L. IT WAS CORRECTED BY THE HOSPITALIZATION TREATMENT AND VIA BOLUS PUMP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19369275 ↗
• MalfunctionMay 13, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, THE PATIENT REPORTED THAT THE INFUSION SET HAD BEEN LEAKED AND LOCATION OF LEAKAGE WAS AT SITE. PATIENT'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 20 MMOL/L. PATIENT WAS TREATED WITH MANUAL INJECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19298970 ↗
• MalfunctionMay 10, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED A LEAKAGE OF INFUSION SET. THE INFUSION SET WAS USED FOR 1-2 DAYS AND SITE WAS PATIENT'S TUMMY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283981 ↗