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

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 05705244005778), received between Jan 17, 2018 and Sep 18, 2026 — classified as 1 death, 18 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (77 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 102 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Handling Problem

  Patient problems: Hypoglycemia

  MAUDE report 50822402 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  It was reported that patient faced insulin did not exit the tubing event on (b)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50447910 ↗
• InjuryAug 17, 2026Fluid/Blood Leak

  It was reported that patient experienced infusion set was leaking at the tubing on (b)(6) 2026 which led to high blood glucose and it was addressed by correction bolus.

  Patient problems: Hyperglycemia

  MAUDE report 50268948 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced high blood glucose and it was corrected by insulin pen event on (b)(6)2026.

  Patient problems: Hyperglycemia

  MAUDE report 50141605 ↗
• MalfunctionAug 3, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108754 ↗
• InjuryJul 7, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE TREATED WITH INJECTION ON (B)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 25734527 ↗
• DeathJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED AND DIED ON (B)(6) 2020 AND THE CAUSE OF DEATH IS HEART ATTACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500641 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED HYPERGLYCEMIA EVENT ON (B)(6) 2026 AND TREATED WITH INSULIN USING PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 24964331 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER FAINTING DUE TO HYPOGLYCEMIA, AND THE LOW BLOOD GLUCOSE EVENT WAS TREATED WITH INTRAVENOUS INSULIN AND PUMP THERAPY.

  Patient problems: Hypoglycemia

  MAUDE report 24964173 ↗
• MalfunctionSep 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COSTA RICA. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975315 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2025. THE BLOOD GLUCOSE VALUE WHEN ADMITTED TO THE HOSPITAL WAS 307 MG/DL. THE PATIENT TESTED FOR KETONES, AND THE RESULTS WERE 2.7. THE REASON FOR HOSPITALIZATION WAS KETOACIDOSIS. INSULIN WAS ADMINISTERED INTRAVENOUSLY WHILE AT THE HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR MORE THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 21888136 ↗
• MalfunctionAug 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING OCCLUSION EVENT ON (B)(6) 2024. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904978 ↗
• MalfunctionJul 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT FACED AN ADHESIVE EVENT WITH AN INFUSION SET WHICH WAS LOST AS IT GOT UNPLUGGED FROM BODY BECAUSE OF TAPE ISSUES WHEN THE PATIENT WAS PLAYING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718567 ↗
• MalfunctionJun 19, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCK ALARM. MOREOVER, INSULIN DID NOT EXIT WITH PLUNGER PUSH NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566069 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Mechanical Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE NETHERLANDS. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN DELIVERY ISSUE AND STATED THAT INSULIN WAS DRIPPING OR SQUIRTING FROM THE END OF THE SET DURING THE LAST SET CHANGE BEFORE CONNECTING IT AT THE CUSTOMER'S SITE. A LOW BLOOD GLUCOSE EVENT (LOW BGS) WAS REPORTED BY THE PATINET, WHO EXPERIENCED A SIGNIFICANT HEALTH RISK DUE TO THE INSULIN DELIVERY ISSUE. HOWEVER, THEY TREATED THE LOW BLOOD GLUCOSE (LOW BG) EVENT BY CONSUMING SOME CARBOHYDRATES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 19327928 ↗
• InjuryFeb 2, 2024Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Device Difficult to Program or Calibrate; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN HONG KONG. ON 27-JAN-2024, THE PATIENT'S PARENT REPORTED THAT THEIR CHILD'S INFUSION SET NEEDLE HAD BROKEN OFF WHILE THE IMPLANT WAS IN THE ABDOMEN. THERE WAS NO NEEDLE WHEN INFUSION SET WAS REMOVED, BUT THE IMPLANT SITE FELT ITCHY AND HARD BULGE WAS SEEN UNDER THE SKIN. MOREOVER, THE INFUSION SET HAD BEEN USED FOR 3 DAYS. THEREFORE, THE PARENTS TOOK THE CHILD FOR COMPUTED TOMOGRAPHY (CT) SCAN AND ON 24-JAN-2024 AT 23:17 PM, THE TEST RESULTS CONFIRMED THAT THE BROKEN NEEDLE WAS UNDER THE SKIN. MOREOVER, THE CHILD'S BLOOD GLUCOSE LEVEL WAS 20 MMOL/L AND INSULIN PUMP WERE USED TO CONTROL BLOOD GLUCOSE LEVEL. FURTHER, ON 25-JAN-2024 AT NOON, IT WAS INFORMED THAT THE NEEDLE WAS SURGICALLY REMOVED IN THE HOSPITAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 18634243 ↗
• MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2023, IT WAS REPORTED THAT THE INFUSION SET'S TUBING GOT DETACHED. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966151 ↗
• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CZECH REPUBLIC. ON (B)(6) 2022, IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET'S TUBING BROKE INTO HALF. THE SITE LOCATION WAS LEFT SIDE OF PATIENT'S BUTTOCK AND THE PUMP WAS ON THE BELT. 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 16377742 ↗
• MalfunctionSep 24, 2021Detachment 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) 2021, IT WAS REPORTED THAT, THE PATIENT'S INFUSION SET'S TUBING ON THE QUICK RELEASE WAS COMING OUT ON ITS OWN. THIS ISSUE OCCURRED ON 2 DIFFERENT OCCASIONS, MOST RECENTLY OVERNIGHT. THE PATIENT'S BLOOD GLUCOSE LEVEL AT BEDTIME WAS 120 AND OVERNIGHT IT WAS MORE THAN 300MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 12524592 ↗
• InjuryMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (ABOVE 400 MG/DL) DUE TO A BENT CANNULA. THEREFORE, HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL FOR OVER 40 DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11869252 ↗
• InjuryJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  UNOMEDICAL REFERENCE NUMBER: (B)(4). A DIABETIC FEMALE PATIENT REPORTED THAT THE INFUSION SET WAS LEAKING ON SITE AND NOT DELIVERING INSULIN AND SHE WENT INTO A COMA AND WAS HOSPITALIZED. PATIENT HAD LEAKS IN HER SITE, ESPECIALLY WHEN SHE DOES A BOLUS. PATIENT STATED THAT THERE WAS NOT ANY STRESS OR PULL ON THE INFUSION SET TUBING. PATIENT WAS ABLE TO CHANGE THE INFUSION SET. THERAPY AT HOSPITAL IS UNKNOWN. DATE OF INCIDENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Coma

  MAUDE report 11121616 ↗
• InjuryNov 20, 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, THE PATIENT REPORTED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE. THEREFORE, SHE DECIDED TO CHECK AND POTENTIALLY CHANGE HER INFUSION SET. AT THIS TIME, SHE REPORTED THAT CANNULA WAS NOT PRESENT WHEN SHE REMOVED THE INFUSION SET AS SHE NOTICED THAT THE NEEDLE HAD DETACHED. FURTHER, ON MONDAY, (B)(6) 2020, SHE SAW HER PHYSICIAN AND HER X-RAY CONFIRMED THAT THE NEEDLE WAS IN HER ABDOMEN. THE NEXT DAY, ON TUESDAY, (B)(6) 2020, THE SURGEON WAS INVOLVED TO REMOVE THE NEEDLE AND ON THURSDAY, (B)(6) 2020, THE SURGEON REMOVED THE NEEDLE IN AN OUTPATIENT PROCEDURE THAT TOOK PLACE IN THE HEALTH CARE PROFESSIONAL'S OFFICE. REPORTEDLY, ON (B)(6) 2020, HER STITCHES WERE REMOVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 10873107 ↗
• MalfunctionJul 14, 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 THE PATIENT NOTICED THAT THE INFUSION SET'S TUBING BECAME LOOSE (CAME APART), CLOSE TO THE SITE LOCATION WHILE SITTING AND HE WAS JUST TO KEEP THE INFUSION SET IN HIS POCKET. THE SITE LOCATION WAS RIGHT ABDOMEN THE FIRST TIME IT HAPPENED, AND YESTERDAY WAS ON HIS LEFT ABDOMEN AND THE PUMP WAS ON THE SAME SIDE, THAT THE INFUSION SET WAS INSERTED. THE INFUSION WAS INSERTED IN THE MORNING AND IT CAME LOOSE AFTER LUNCH. 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 THEIR BODY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 113 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10269774 ↗
• MalfunctionJul 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH THE INFUSION SET YESTERDAY. REPORTEDLY, WHEN HE WENT TO PUT THE SET ON AND THE MIDDLE PORTION WHERE THE QUICK RELEASE IS, IT WOULD NOT CLICK AND STAY ON. THEREFORE, HE TOOK THE SET OFF AND TRIED A NEW SET AND HAD NO ISSUES. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR AND THE GLUE WAS MISSING FROM THE TUBBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10228748 ↗
• InjuryJun 9, 2020Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020 AT 9:00 PM, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL OF 26.5 MMOL/DL, DUE TO LEAKAGE IN THE INFUSION SET. REPORTEDLY, THE LEAK WAS 15 CM FROM THE RESERVOIR AND THERE WAS A CUT IN THE TUBING, BUT THE TUBING DID NOT COME APART. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS DRIP (DRUG NAME UNKNOWN). AS PER REPORT DATED, (B)(6) 2020 AT 3:57 PM, THE PATIENT WAS STILL IN THE HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10131986 ↗