Sure-T® Paradigm® MMT-866Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 05705244006058), received between Jan 8, 2019 and Apr 22, 2026 — classified as 4 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (60 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 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH THE INFUSION SET ON (B)(6) 2023 AS THE NEW INFUSION SET TUBING CONNECTOR WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951230 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE PATIENT REPORTED THAT THE INFUSION SET WAS LEAKING AT THE INSERTION SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699640 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH THE INFUSION SET ON (B)(6) 2023 AS THE NEW INFUSION SET TUBING CONNECTOR WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699084 ↗
• MalfunctionMay 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON 24-APR-2024, THE PATIENT REPORTED THE EVENT OF INFUSION SET TUBING DETACHMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398620 ↗
• MalfunctionMay 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398619 ↗
• InjuryMay 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL (AROUND 22.2 MMOL/L). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19328737 ↗
• MalfunctionMay 7, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON 12-APR-2024, IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT EXPERIENCED NO DELIVERY ALARMS. THE ISSUE WAS RESOLVED BY INFUSION SET CHANGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264084 ↗
• MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT THE QUICK RELEASE CAN BE TURNED AND DISCONNECTED WITHOUT HOLDING THE TWO SIDES. THEREFORE, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 23 MMOL/L AND THE PATIENT'S MOTHER IMMEDIATELY CORRECTS IT BY REPLACING THE LINE AND IMPLANT THE SITE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 15985117 ↗
• InjuryMay 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, IT WAS REPORTED THAT A (B)(6) MALE (THIN BODY) PATIENT WITH TYPE 2 DIABETES WAS ADMITTED IN THE HOSPITAL. PREVIOUSLY, (B)(6) 2022, THE PATIENT WAS GIVEN A PUMP INFUSION OF INSULIN TO CONTROL HIS BLOOD GLUCOSE LEVEL AND A SUBCUTANEOUS IMPLANTATION OF AN INFUSION LINE IN THE PATIENT'S ABDOMEN. THEREFORE, HIS BLOOD GLUCOSE VALUE WAS MEASURED IN THE AFTERNOON OF THE NEXT DAY WHICH SHOWED 20 MMOL/L. THE HOSPITAL IMMEDIATELY CORRECTED IT BY INSULIN NUMBER WHEN HE USED THE BOLUS BUT DID NOT ACHIEVE THE EXPECTED EFFECT. ON THE MORNING OF THE 1ST ((B)(6) 2022) THE NURSE FOUND THAT THE MISSING NEEDLE WAS FOUND WHEN CHANGING THE NEEDLE AND AFTER TAKING THE FILM AT ABOUT 11 O'CLOCK ON THE SAME DAY IT WAS FOUND THAT THERE WAS A FOREIGN BODY UNDER THE SKIN OF THE ABDOMEN AND THE HOSPITAL ARRANGED FOR SURGERY TO TAKE THE NEEDLE IN THE AFTERNOON OF THE SAME DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 14386213 ↗
• InjuryFeb 3, 2022Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, FATIGUE AND CHEST PAIN BECAUSE OF AN INSULIN FLOW BLOCKED ALARM. THE INFUSION SET HAD BEEN USED FOR A COUPLE OF HOURS. CONSEQUENTLY, ON (B)(6) 2022, THE PATIENT WAS ADMITTED IN THE HOSPITAL AS THE BLOOD GLUCOSE LEVEL WAS 744 MG/DL AND KETONES WERE 80 MMOL/L. MOREOVER, THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND WAS RELEASED AFTER THREE DAYS. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 102 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 13439768 ↗
• MalfunctionMar 31, 2021Detachment 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 NEW INFUSION SET'S TUBING DISCONNECTED AT THE TUBING CONNECTOR. THEREFORE, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NORMAL AND DID NOT REQUIRED MEDICAL TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594422 ↗
• MalfunctionFeb 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED ON 10-DEC-2020, THAT THE PATIENT'S INFUSION SET'S TUBING GOT DISCONNECTED AT THE TUBING CONNECTOR. FURTHER, THE PATIENT'S BLOOD GLUCOSE WAS NORMAL AND DID NOT REQUIRE ANY MEDICAL TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336221 ↗
• MalfunctionJan 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, IT WAS REPORTED THAT IN THE MORNING, WHEN THE PATIENT WOKE UP, HER INFUSION SET'S TUBING GOT DETACHED FROM THE CONNECTOR AND HER BLOOD GLUCOSE LEVEL WENT HIGH (280 MG/DL). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11129969 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 30-NOV-2020, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED FROM THE CONNECTER IN THE MORNING WHEN THE PATIENT WOKE UP. REPORTEDLY, HER BLOOD GLUCOSE LEVEL WAS 280 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10973069 ↗
• MalfunctionDec 8, 2020Detachment 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 PATIENT'S INFUSION SET'S TUBING BECAME DISCONNECTED ON THE QUICK RELEASE, WHILE SHE WAS SLEEPING. FURTHER, SHE DOES NOT KNOW IF IT GOT PULLED OUT AS SHE WOKE UP AND SAW THAT THE TUBING WAS OUT. THE SITE LOCATION WAS ON LEFT SIDE OF HER ABDOMEN AND THE PUMP WAS PLACED ON THE BED NEXT TO HER WHEN SHE IS SLEEPING. THE INFUSION HAD BEEN USED FOR AT LEAST 24 - 48 HRS. 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. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 120 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972974 ↗
• MalfunctionOct 27, 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 PATIENT'S INFUSION SET'S TUBING HAD DETACHED WHILE INSERTING A NEW INFUSION SET. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. THE INFUSION HAD BEEN USED FOR THE FIRST DAY. 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 10745008 ↗
• MalfunctionOct 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 08-JUL-2019, IT WAS REPORTED THAT LAST FRIDAY SHE WAS HIGH THE WHOLE DAY AND DID NOT KNOW WHAT HAD HAPPENED. REPORTEDLY, WHEN SHE WENT TO THE BATHROOM, SHE NOTICED THAT THE TUBING OF HER INFUSION SET WAS DISCONNECTED TO THE SITE CONNECTOR WHILE SWIMMING. THE SITE LOCATION WAS ON LOWER RIGHT SIDE OF HER ABDOMEN AND THE PUMP WAS LOCATED ON THE MIDDLE PART OF HER ABDOMEN. THE INFUSION HAD BEEN USED FOR TWO DAYS. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY, BUT THE WEATHER WAS TOO HOT. 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. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1), IT WAS NOTICED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE). THE CONNECTOR WAS FOUND WITH A GLUE DROP ON IT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10738974 ↗
• MalfunctionAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED LEAKS AT THE TUBING CONNECTOR, AS THE INFUSION SET'S TUBING DETACHED AT THE TUBING CONNECTOR WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S BELLY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE WHETHER THERE WAS ANY 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 Known Impact Or Consequence To Patient

  MAUDE report 10384004 ↗
• MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 20-JUL-2020, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED FROM THE QUICK RELEASE. HOWEVER, THE PATIENT'S BLOOD GLUCOSE WAS NORMAL AND DID NOT REQUIRE ANY MEDICAL TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10366250 ↗
• MalfunctionMar 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE) AND ALSO A DROP OF GLUE WAS FOUND ON THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING BROKE OFF AT THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864034 ↗
• MalfunctionMar 19, 2020Detachment 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 HE WOKE WITH HIGH BLOOD GLUCOSE LEVELS OF 407 MG/DL. MOREOVER, HE NOTICED AIR BUBBLES IN THE RESERVOIR (BASAL). REPORTEDLY, THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE. FURTHER, HE ALSO STATED THAT THERE WAS BLOOD COMING UP THE TUBE FROM THE BODY BUT WAS NO LONGER BLEEDING. UPON INVESTIGATION, OF THE RETURNED USED DEVICE (1 SET), IT WAS NOTICED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9851804 ↗
• MalfunctionFeb 26, 2020Detachment 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

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL CLOSE TO 400 MG/DL AS THE INFUSION SET'S TUBING HAD DETACHED AT THE SITE PORTION, WHILE SITTING WHEN THE PATIENT WAS AT WORK. THE SITE LOCATION WAS PATIENT'S RIGHT STOMACH AREA ABOVE NAVEL AS THE PATIENT HAD PAIN/DISCOMFORT ON THE SIDE LOCATION OF THE STOMACH AND THE PUMP WAS LOCATED AT THE RIGHT SIDE. MOREOVER, THE INFUSION HAD BEEN USED FOR A DAY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, THEY WERE UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 125 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9754916 ↗
• MalfunctionFeb 4, 2020Detachment 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 WORKING ON THE COMPUTER, IT WAS NOTICED THAT THE INFUSION SET'S TUBING HAD DETACHED ON THE PART WHERE IT WAS INSERTED TO BODY. THE SITE LOCATION WAS ON THE LEFT SIDE OF THE PATIENT'S ABDOMEN AND THE PUMP WAS CLIPPED ON TO THE BRA. THE INFUSION HAD BEEN USED FOR ONE DAY. 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, OF THE RETURNED USED (1 TUBING), IT WAS FOUND THAT THE GLUE WAS MISSING IN 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 9669116 ↗
• MalfunctionDec 24, 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 PATIENT'S INFUSION SET'S TUBING HAD DISCONNECTED AT THE TUBING CONNECTOR. REPORTEDLY, THE PATIENT BLOOD GLUCOSE LEVEL WAS NORMAL AND DID NOT REQUIRE ANY MEDICAL TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9514411 ↗
• InjuryNov 30, 2019Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT A CHILD PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. THE PATIENT TOOK 12 UNITS OF INSULIN BUT THAT DID NOT WORK, SO 12 UNITS OF INSULIN WERE TAKEN AGAIN. SUBSEQUENTLY, IN THE MORNING OF (B)(6) 2019, THE PATIENT WAS HOSPITALIZED, AND IT WAS STATED THAT THE CATHETER HAD A HOLE AND IT WAS LEAKING. THEREFORE, INSULIN WAS COMING OUT OF THE TUBING. NO ALARMS FOUND ON THE PUMP ACCORDING TO NURSE. REPORTEDLY, THE PATIENT WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT ON 29 OCT-2019. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9392209 ↗