Silhouette® Paradigm® MMT-381Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05705244008588), received between Dec 18, 2017 and Sep 26, 2026 — classified as 1 death, 10 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Device Handling Problem

  Patient problems: Hyperglycemia

  MAUDE report 50907573 ↗
• InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperglycemia

  MAUDE report 50629994 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced high blood glucose event on (b)(6) 2026 and was treated with insulin pen.

  Patient problems: Hyperglycemia

  MAUDE report 50269860 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had high blood glucose and treated with insulin pump on (b)(6)2026

  Patient problems: Hyperglycemia

  MAUDE report 50189858 ↗
• DeathJun 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE AND WAS LATER DECEASED DUE TO HEART CONDITION AND HYPOTENSION ADRENAL INSUFFICIENCY ON (B)(6) 2020.

  Patient problems: Hypoglycemia

  MAUDE report 25495546 ↗
• InjuryApr 13, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE WHICH GOT TREATED WITH BOLUS. THE BLOOD GLUCOSE WAS BEEN HIGH FOR 4 HOURS.

  Patient problems: Hyperglycemia

  MAUDE report 24855941 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT FACED CANNULA ISSUE ON (B)(6) 2026. THE INFUSION SET CANNULA WAS BENT AND THE PATIENT EXPERIENCED PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24731211 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT FACED CANNULA ISSUE ON (B)(6) 2026. THE INFUSION SET CANNULA WAS BENT AND THE PATIENT EXPERIENCED PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24730266 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4) EVENT COUNTRY IN SWITZERLAND. IT WAS REPORTED THAT THE THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE

  Patient problems: Pain

  MAUDE report 24728111 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4) EVENT COUNTRY IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24726215 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4). EVENT COUNTRY IN THE SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24725958 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4). EVENT COUNTRY IN THE SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24725938 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE CANNULA SITE DURING PHYSICAL ACTIVITY ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701339 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CZECH REPUBLIC. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE SITE ON (B)(6) 2023, AFTER THE INFUSION SET HAD BEEN IN USE FOR 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701337 ↗
• MalfunctionFeb 10, 2026Complete Blockage; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2026. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301311 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON 13-AUG-2025. THE SITE OF DETACHMENT WAS CLOSE TO SITE LOCATION. THE INFUSION SET WAS IN USE FOR ONE DAY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034882 ↗
• MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON 13-AUG-2025. THE SITE OF DETACHMENT WAS CLOSE TO SITE LOCATION. THE INFUSION SET WAS IN USE FOR ONE DAY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023838 ↗
• MalfunctionApr 18, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET WAS LEAKING IN THE CANNULA SIDE AT QUICK RELEASE SITE ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864068 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET WAS LEAKING IN THE CANNULA SIDE AT QUICK RELEASE SITE ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855535 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET CANNULA KINKED EVENTS ON (B)(6) 2025. COMPANY 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544749 ↗
• MalfunctionDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED OCCLUSION AT THE TUBING EVENT ON (B)(6) 2024. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862391 ↗
• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA TUBING WAS DETATCHED CLOSE TO THE CANNULA EVENT ON (B)(6) 2024. SITE OF INSERTION WAS ABDOMEN. INFUSION SET WAS IN USE FOR 12 HOURS. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703595 ↗
• MalfunctionOct 9, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKING AT THE TUBING EVENT ON (B)(6) 2024. THE INFUSION SET HAS BEEN USED FOR 2 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407953 ↗
• MalfunctionOct 9, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKING AT THE TUBING EVENT ON (B)(6) 2024.THE INFUSION SET HAS BEEN USED FOR 2 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407846 ↗
• MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON 04-SEP-2024. THE LOCATION OF DETACHMENT WAS AT SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368404 ↗