Sure-T® Paradigm® MMT-886Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05705244006034), received between Jan 21, 2019 and Aug 6, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Premature Separation

  Patient problems: Skin Infection

  MAUDE report 50156969 ↗
• MalfunctionFeb 20, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBE BLOCKAGE. TROUBLESHOOTING CONFIRMED THAT THE BLOCKAGE WAS IN THE TUBE. THIS EVENT OCCURRED ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418502 ↗
• MalfunctionAug 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT COMPLAINED ABOUT INFUSION SET FELL OFF DURING SHOWER DUE TO TAPE NOT STICKING ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 19916403 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN SPAIN ON (B)(6) 2023, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE. THE SITE LOCATION WAS PATIENT'S ABDOMEN. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16394769 ↗
• MalfunctionOct 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT THAT SHE HAD A SET THAT CAME OUT FROM HER BODY WHILE SHE WAS CHANGING CLOTHES. THE SITE LOCATION WAS HER ABDOMEN AND THE PUMP WAS LOCATED IN HER BRA. THE INFUSION HAD BEEN USED FOR LESS THAN 24 HOURS. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10625020 ↗
• MalfunctionJul 12, 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 SHE WAS IN THE PROCESS OF CHANGING HER INFUSION SET AND HAD NOT FULLY CONNECTED IT, THE INFUSION SET'S TUBING CAME APART. THE LOCATION OF DETACHMENT WAS SITE TO CONNECTOR TUBING. THE SITE LOCATION WAS ABDOMEN AND THE PATIENT DID NOT HAVE THE PUMP ON HER. REPORTEDLY, THE INFUSIONS WERE STORED IN THE BEDROOM 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. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (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 8784175 ↗
• MalfunctionJun 17, 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'S FATHER REPORTED THAT IN ONE OF THE SETS, AFTER HAVING LUNCH, THE PATIENT'S BLOOD GLUCOSE LEVEL STARTED GOING UP (550 MG/DL) AND THE FATHER REPLACED HIS SET. WHEN THE PATIENT'S FATHER TOOK THE OLD SET OFF, THE ENTIRE NEEDLE BROKE OFF INTO THE PATIENT'S BODY AND IT STAYED IN IT. TWO DAYS BEFORE THE EVENT, THE FIRST SET WAS INSERTED, AND HIS FATHER GAVE HIM A MANUAL INJECTION. ON THE DAY OF THE EVENT, THE PATIENT HAD TO GO TO THE HOSPITAL TO GET THE NEEDLE REMOVED. HE VISITED THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL AROUND 120 MG/DL. THE SET'S INSERTION LOCATION WAS AT THE UPPER BUTTOCK AREA. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS. THE PATIENT UNDERWENT SURGERY AS MEDICAL TREATMENT TO REMOVE THE NEEDLE FROM THE BODY. ON THE DAY OF THIS REPORT, IT WAS STATED THAT THE NEEDLE WAS NOT IN HIS BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 8703243 ↗
• MalfunctionMay 22, 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'S FATHER REPORTED THAT THE INFUSION SET WAS INSERTED, AND MANUAL INJECTION WAS GIVEN TO THE PATIENT. AFTER TWO DAYS OF INFUSION SET USE, THE PATIENT HAD LUNCH AND HIS BLOOD GLUCOSE LEVEL STARTED TO GO UP. HIS BLOOD GLUCOSE LEVEL WAS 550 MG/DL WHEN THE FATHER TOOK THE OLD INFUSION SET OFF TO REPLACE IT. IT WAS FOUND THAT THE NEEDLE WAS NOT ATTACHED TO THE SET AND THE ENTIRE NEEDLE BROKE OFF INTO THE PATIENT'S BODY. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY, ADMITTED TO THE HOSPITAL TO GET THE NEEDLE REMOVED WITH BLOOD GLUCOSE LEVEL AT AROUND 120 MG/DL. THE PATIENT RECEIVED MEDICAL TREATMENT IN THE FORM OF A SURGERY TO REMOVE THE NEEDLE THAT HAD FRACTURED INSIDE THE PATIENT'S BODY. THE INFUSION SET INSERTION LOCATION WAS IN UPPER BUTT AREA. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 8630576 ↗
• MalfunctionApr 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP, FOUND OUT THAT TUBING WAS DETACHED FROM THE QUICK RELEASE AND HAD HIGH BLOOD GLUCOSE LEVEL. THE SITE WAS AT THE LEFT ABDOMEN AND THE PUMP WAS JUST BESIDE THE PATENT ON BED. THE INFUSION SET HAD BEEN IN USE FOR THE SECOND DAY. 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 GLUE WAS MISSING FROM THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8534846 ↗
• InjuryMar 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 STATED THAT THE NEEDLE BROKE OFF AND IT STAYED INSIDE UNDER HER SKIN. REPORTEDLY, NEEDLE WAS STILL UNDER HER SKIN AND WILL HAVE TO BE REMOVED BY A SURGEON. (SURGERY NOT SCHEDULED AT THIS TIME). THE PATIENT STATED SHE DID NOT NOTICE THE NEEDLE IN HER BODY UNTIL HER BG WENT UP AND SHE WENT TO REMOVE THE INFUSION SET. CUST STATES THIS IS THE SECOND TIME THIS HAS HAPPENED. THE INFUSION SET WAS IN USE FOR THREE DAYS, HOWEVER, IFU RECOMMEND MAX USE OF THE INFUSION SET FOR 48 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 8380968 ↗
• MalfunctionFeb 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (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 ONE HOUR AFTER CHANGING THE SET. THE PATIENT HAD THIS ISSUE WITH FIVE SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324845 ↗
• MalfunctionFeb 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 TUBING DETACHMENT CLOSE TO QUICK RELEASE WHEN THE PATIENT JUST FINISHED EATING AND WAS DOING DISHES. THE SITE LOCATION WAS AT THE ABDOMEN AND THE PUMP WAS CLIPPED ON THE LEFT SIDE ON THE WAIST LINE. REPORTEDLY, IT WAS THE SECOND DAY OF INFUSION BEING USED. THE INFUSIONS WERE STORED IN THE CONDITIONED ROOM AND THE PATIENT WAS UNSURE ABOUT THE 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 8300450 ↗
• MalfunctionJan 21, 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 GOT LOOSE AT SITE OF QUICK RELEASE. THE PATIENT DID NOT NOTICE UNTIL BLOOD GLUCOSE LEVEL WAS 22 MMOL/L LAST. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265880 ↗