Sure-T® Paradigm® MMT-874Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05705244005792), received between Jan 19, 2019 and Mar 26, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HYPOGLYCEMIA ON (B)(6) 2026. THE PATIENTS BLOOD GLUCOSE LEVEL WAS 20 MG/DL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 24701182 ↗
• MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10-MAR-2022: FOLLOW UP INFORMATION WAS SUBMITTED TO ADD DATE OF THIS REPORT AND TO UPDATE THE AWARENESS DATE. MOREOVER, THE RESULT OF COMPLAINT INVESTIGATION OF RETURNED USED DEVICE (ONE SET), SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR AND EXCESS OF GLUE WAS NOTICED WHERE TUBING WAS JOINED ON THE TUBING CONNECTOR. BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 19-AUG-2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART AT THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S ABDOMEN, AND THE PUMP WAS ON THE SAME SIDE IN RELATION TO THE SITE. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. 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, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 12411857 ↗
• MalfunctionDec 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED THAT, LAST NIGHT WHEN THE PATIENT WENT TO BED, THE INFUSION SET'S TUBING DETACHED AT THE TUBING CONNECTOR AND NOTICED IT WHEN THE PATIENT WOKE UP. THE SITE LOCATION WAS PATIENT'S LEFT ABDOMEN AND THE PUMP WAS IN THE LEFT SIDE. MOREOVER, THE INFUSION WAS NOT USED FOR MORE THAN TWO DAYS. 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 PATIENT'S BODY. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 280 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10989212 ↗
• MalfunctionDec 6, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON 06-MAR-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING HAD DETACHED AT THE SITE LOCATION. REPORTEDLY, THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS ALSO LOCATED ON THE ABDOMEN. THE INFUSION HAD BEEN USED FOR TWO DAYS. 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9422590 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET TUBING WAS DAMAGED OUT OF THE BOX. FURTHER, THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE CONNECTION WITH THE CANNULA. THE INFUSIONS WERE STORED IN A CLOSET. 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 9189900 ↗
• MalfunctionSep 5, 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 THE INFUSION SET'S TUBING DETACHED FROM THE QUICK RELEASE PART DURING NORMAL USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8963570 ↗
• InjuryApr 22, 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 MOTHER REPORTED THAT SHE INSERTED THE INFUSION SET ON HER DAUGHTER AND THE ISSUE OCCURRED 2 DAYS LATER. THE PATIENTS BLOOD GLUCOSE LEVEL WENT UP TO 16 AND 24 MMOL/L THAT DAY AND WHEN SHE REMOVED THE SET SHE FOUND THAT THE NEEDLE WAS MISSING. SET WAS INSERTED ON HER BUTTOCK. REPORTEDLY, THERE WAS NO REDNESS AND DISCHARGE, BUT THE PATIENT HAD PAIN AT THE SITE. THE DOCTOR AT THE HOSPITAL RECOMMENDED A PLASTIC SURGEON TO DO THE SURGERY AND THE PATIENT HAD TO UNDERGO SURGERY. IN THE INVESTIGATION IT WAS FOUND THAT THE PICTURE OF THE STEEL INTRODUCER NEEDLE WAS BROKEN INSIDE TO THE SKIN OF THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 8534866 ↗
• MalfunctionApr 1, 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 TUBING DETACHMENT AND STATED THAT WHILE SHE WAS CHANGING HER SET, SHE PUT IT ON HER BODY AND THE END POPPED OUT. THE INFUSION SET DISCONNECTED AND THE PIECE THAT WAS IN HER BODY POPPED OFF AT THE SITE. PATIENT'S WEIGHT WAS (B)(6). UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469611 ↗
• 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 WHILE SLEEPING, THE INFUSION SET'S TUBING DETACHED. SHE STATED THAT AS SHE WOKE UP, AND FOUND HER TUBING WAS DETACHED FROM HER INFUSION SET AND NOTICED THAT SHE HAD HIGH BLOOD GLUCOSE LEVEL. REPORTEDLY, THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL CURRENTLY AND AT THE TIME OF INCIDENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8468121 ↗
• MalfunctionJan 19, 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 WHILE GETTING DRESSED, THE PATIENT WAS CHANGING THE SITE AND THE TUBING DETACHED AT THE QUICK RELEASE AND IT WAS A CLEAN-CUT DETACHMENT. THE SITE WAS AT THE ABDOMEN AND THE PUMP WAS WORN ON THE RIGHT SIDE. THE PATIENT HAD JUST PUT ON THE SET WHEN THE DETACHMENT OCCURRED. 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8263048 ↗