Sure-T® Paradigm® MMT-862Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05705244005495), received between Jan 15, 2019 and Aug 31, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced high blood glucose of 400mg/dl and was treated with bolus delivered via the pump on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50517668 ↗
• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN NETHERLANDS ON (B)(6) 2020, THE PATIENT'S MOTHER REPORTED THAT THE INFUSION SET'S NEEDLE BROKE OFF IN THE BODY. THE INFUSION SET WAS INSERTED LAST WEEKEND IN THE PATIENT'S BUTTOCK. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377881 ↗
• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT NOTICED THE INSULIN OUT OF THE TUBING AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH TWO INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10565213 ↗
• InjuryMar 13, 2020Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, THE PATIENT REPORTED A PAST EVENT AS SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND INSULIN FLOW BLOCKED BUT THE ALARM DID NOT OCCUR. THEREFORE, SHE TRIED TO TREAT HIGH BLOOD GLUCOSE LEVEL WITH A BOLUS. CONSEQUENTLY, ON (B)(6) 2019, THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT OF THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OVER 1100 MG/DL, WHERE SHE RECEIVED INTRAVENOUS FLUIDS AND INSULIN DRIP AS CORRECTIVE TREATMENT. FURTHER, THE INFUSION SET WAS CHANGED ON THE SAME DAY ((B)(6) 2019). THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR THREE DAYS. MOREOVER, IT WAS STATED THAT THE EVENT WAS RESOLVED BY CHANGING COMPLETE SET (INFUSION AND RESERVOIR). REPORTEDLY, A DAY BEFORE THIS REPORT ((B)(6) 2020), THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL AND THE INFUSION SET WAS CHANGED ON THE SAME DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9828249 ↗
• MalfunctionMay 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE HAD AN INFUSION SET THAT DETACHED AT CLEAR TUBING CAP WHEN SHE WAS GETTING READY FOR SHOWER WITH BLOOD GLUCOSE LEVEL GOING UP TO 300 MG/DL. THE SITE LOCATION WAS AT THE STOMACH AND THE PUMP WAS ON THE SAME SIDE. REPORTEDLY, THE INFUSIONS WERE STORED IN A ROOM. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8576885 ↗
• MalfunctionApr 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT THE TUBE WAS DETACHED FROM THE OTHER PART NOT THE PART THAT IS ATTACHED TO HIS NEEDLE AND THE PATIENT WAS NOT GETTING ANY INSULIN. HIS BLOOD GLUCOSE LEVEL WAS 26 MMOL/L AND KETONE LEVEL WERE 1.6 MMOL/L. PATIENT WAS VOMITING BUT HIS PEDIATRICIAN WAS KEEPING AN EYE ON HIM. HIS SUGAR CAME DOWN A LITTLE SINCE HE INSERTED ANOTHER SET. THIS SAME ISSUE OCCURRED AGAIN AS THE TUBING GOT DETACHED AND HE WOKE UP HIGH. AT THE TIME OF THIS REPORT, HIS BLOOD GLUCOSE LEVEL WAS 9.5 MMOL/L AND HAD NO KETONES. PATIENT'S FATHER STATED THAT THE PATIENT WAS DOING FINE, AND HE HAD SOME ACTIVE INSULIN AS WELL, SO HE WILL CONTINUE TO GET EVEN BETTER. IN THE INVESTIGATION IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8559885 ↗
• MalfunctionApr 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT SOME TIME AGO HE NOTICED THAT THE TUBING DETACHED FROM THE QUICK RELEASE RIGHT AFTER HE OPENED STERILE BOX WITH THE SET. REPORTEDLY, THE INFUSIONS WERE NOT STORED IN PLACE WHERE THEY COULD HAVE BEEN EXPOSED TO EXTREME TEMPERATURES, STORED THE SETS IN WARDROBE AT ROOM TEMPERATURE. 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 Known Impact Or Consequence To Patient

  MAUDE report 8538669 ↗
• InjuryApr 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE CANNULA WAS COMING OUT AND DID NOT NOTICED IT HAD COME OUT. PATIENT'S BLOOD GLUCOSE LEVEL WENT UP TO 1125 MG/DL. THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL FOR 11 DAYS. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 139 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8535355 ↗
• MalfunctionApr 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN COMING OUT OF THE TUBING 1 HOUR AFTER THE CHANGE OF SET. IT OCCURRED WITH 1 SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502730 ↗
• MalfunctionApr 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET TUBING HAD DETACHED AT THE QUICK RELEASE. IT OCCURRED WITH 2 SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502548 ↗
• MalfunctionMar 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE SITE CONNECTOR WHILE THE PATIENT WAS INSERTING THE SET. THE SITE LOCATION WAS PATIENT'S BUTTOCKS AND THE PUMP WAS ON THE LEFT SIDE. 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 NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. FURTHERMORE, A DROP OF GLUE ON TUBING CONNECTOR WAS FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468002 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN THE PATIENT WAS JUST ABOUT TO CHANGE THE SET, THE INFUSION SET TUBING CAME APART AT THE QUICK RELEASE AND WAS NEVER INSERTED, JUST TOOK IT OUT OF PACKAGING, TUBING FELL OUT. 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 NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE) AND WAS NOTICED EXCESS OF GLUE WHERE TUBING WAS JOINED ON THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447256 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT, WHILE DOING NOTHING, HER DAUGHTER'S INFUSION SET'S TUBING WAS DETACHED NEAR THE RESERVOIR AND INFUSION SET ATTACHMENT. THE SITE WAS AT THE ABDOMEN AND SHE WORE THE PUMP BAND ON ABDOMEN. THE INFUSION WAS USED FOR LESS THAN FIVE MINUTES. THE INFUSIONS WERE STORED IN A CLOSET IN THE HOUSE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION, CONNECTOR TESTS WERE PERFORMED ON THE RETURNED SET AND IT WAS FOUND THAT THE TUBING WAS SEPARATED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE AS IT WAS NOT PROPERLY APPLIED BETWEEN TUBING AND TUBING CONNECTOR AND A DROP OF GLUE WAS ALSO PLACED OUTSIDE OF TUBING CONNECTOR.. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338218 ↗
• MalfunctionFeb 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN OUT OF THE TUBING ABOUT 5 HOURS AFTER CHANGING THE SET. THE PATIENT HAD THIS ISSUE WITH ONE SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324480 ↗
• MalfunctionFeb 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN OUT OF THE TUBING AFTER CHANGING THE SET. THE PATIENT HAD THIS ISSUE WITH ONE SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324460 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED TUBING DETACHMENT AT QUICK RELEASE IN ONE SET. THE PATIENT OBSERVED INSULIN COMING OUT OF TUBING ABOUT ONE HOUR AFTER SET CHANGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8314049 ↗
• MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN THEY OPENED THE PACKAGE, THEY NOTICED THAT THE TUBING WAS DISCONNECTED FROM THE TUBING CONNECTOR. 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 NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE COMPLAINT INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. FURTHERMORE, A DROP OF GLUE WAS FOUND ON THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8309037 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT TUBING HAD DETACHED AND IT BECAME LOOSE AT QUICK RELEASE. THE PATIENT INSERTED ON ABDOMEN AND TUBING HAD BEEN IN USE SINCE THE MORNING (DETACHMENT OCCURRED IN EARLY AFTERNOON). NOTHING SIGNIFICANT PRIOR TO DETACHMENT AND THE PUMP WAS NOT BUMPED OR DROPPED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246983 ↗