Sure-T® Paradigm® MMT-864TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244020733), received between Apr 27, 2020 and Nov 15, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY WERE ON THEIR SECOND DAY OF USING THEIR QUICKSET INFUSION SET AND WHEN THEY RODE THEIR BIKE FOR 20 MINUTES THEIR BLOOD GLUCOSE LEVEL WENT FROM 10 MMOL/L TO 23 MMOL/L. THEY WERE UNSURE IF THEIR INFUSION SET WAS WORKING. THE USER BOLUSED WITH PUMP. THE USER HAS ALWAYS USED THE QUICKSET INFUSION SET AND WAS DEVELOPING AN ALLERGY PROBABLY TO THE PLASTIC CANNULA. THE USER DISCONNECTED AND RAN A 5-UNIT FILL CANNULA AND INSULIN EXITED. THE USER ALSO REMOVED THE SITE, CONNECTED BACK TO TUBING, AND RAN INSULIN THROUGH. THE USER DID NOT HAVE SCAR TISSUE AND THEY WERE ADVISED IT MAY BE A SITE RELATED ISSUE AS INSULIN EXITS TUBING WHEN DISCONNECTED. NO FURTHER INFORMATION WAS PROVIDED. THE QUICKSET INFUSION SET WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Skin Inflammation/ Irritation

  MAUDE report 15799017 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCK ALARM WHICH WAS RESOLVED BY INFUSION SET CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INFUSION SET WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320564 ↗
• InjuryMay 7, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER SWITCHED TO A DIFFERENT INFUSION SET. THE CUSTOMER STATED THAT THEY RODE THE EXERCISE BIKE FOR 20 MINUTES AND THE BLOOD GLUCOSE WENT FROM 10 MMOL/L TO 23 MMOL/L. THE CUSTOMER STATED THAT THEY DID NOT KNOW IF THE INFUSION SET WAS WORKING. THE CUSTOMER REPORTED THAT THEY BOLUSED WITH THE INSULIN PUMP. IT WAS REPORTED THAT THE CUSTOMER HAD ALWAYS USED QUICKSET AND WAS DEVELOPING AN ALLERGY PROBABLY TO THE PLASTIC CANNULA. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10035049 ↗
• MalfunctionApr 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INFUSION SET ANOMALY. CUSTOMER ADVISED THE INFUSION SET WAS LOOSE AND DID NOT LOCK WHEN CONNECTED TO THE RESERVOIR. CUSTOMER WAS ADVISED A REPLACEMENT INFUSION WOULD BE SENT OUT. THE DAMAGED INFUSION SET WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000835 ↗