MiniMed™ Silhouette™ MMT-384ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05705244019652), received between Sep 19, 2022 and Apr 19, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE ON 18-MAR-2026 AND HIGH BLOOD GLUCOSE LEVEL WAS TREATED WITH PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 24921069 ↗
• InjuryApr 17, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 AND TREATED IT BY ADMINISTRATING BOLUS. THE BLOOD GLUCOSE WAS 201 MG/DL AND WAS HIGH FOR LESS THAN ONE HOUR.

  Patient problems: Hyperglycemia

  MAUDE report 24908872 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2023. THE TUBE CAME APART FROM THE CANNULA. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712072 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026. THE PATIENT REPORTED SYMPTOMS OF FATIGUE AND WEAKNESS. THE EVENT LASTED MORE THAN FOUR HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24660552 ↗
• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2025 WHILE SLEEPING. THE SITE OF DETACHMENT WAS AT QUICK RELEASE. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE SITE LOCATION WAS ARM. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH INSULIN PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 23529314 ↗
• MalfunctionApr 28, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET TUBING HAD A CRACK ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR LESS THAN 24 HOURS AND PATIENT BLOOD GLUCOSE LEVELS WHILE ADMITTING THE HOSPITAL WAS 474 MG/DL, THEREFORE PATIENT HAD VISITED EMERGENCY ROOM (ER) AND RECEIVED MANUAL INJECTION OF INSULIN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 21916247 ↗
• InjuryJul 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOPSITALIZED DUE TO HIGH BG. PATIENT RECEIVED IV INSULIN DRIP AS A CORRECTIVE TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19779851 ↗
• MalfunctionJul 7, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET WAS LEAKING EVENT ON 05-JUN-2024. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686463 ↗
• MalfunctionJul 6, 2024Detachment 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) 2024, IT WAS REPORTED THAT THE INFUSION SET GOT DETACHED AND PATIENT REPORT INFUSION SET ISSUE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685579 ↗
• MalfunctionJun 30, 2024Device Handling Problem; Device Handling Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE SHE MISTAKENLY INSERTS HER INFUSION SETS THAT CAUSES FOR HER NOT TO BE ABLE TO USE IT ANYMORE AS SHE INSERTED THE INFUSION SET WITH A NEEDLE COVER THAT CAUSES FOR THE INFUSION SET NOT TO INSERT IN HER SKIN. PT REPORTED SHE WAS NOT AWARE THAT SHE CAN GET A REPLACEMENT UNTIL HER TRAINER TOLD HER ABOUT THE SAME. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640797 ↗
• MalfunctionAug 29, 2023Detachment 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) 2023, IT WAS REPORTED THAT THE INFUSION SET'S TUBING GOT DETACHED AT THE TUBING CONNECTOR. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN, AND THE PUMP WAS IN THE WAISTBAND. THE INFUSION HAD BEEN USED FOR LESS THAN A 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 WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639311 ↗
• MalfunctionSep 19, 2022Detachment 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) 2022, IT WAS REPORTED THAT THE INFUSION SET'S TUBING WAS DETACHED FROM THE QUICK RELEASE WHEN THE PATIENT DISCONNECTED IT FOR TAKING SHOWER. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS IN RIGHT POCKET. MOREOVER, THE INFUSION SET WAS USED FOR LESS THAN 24 HOURS. REPORTEDLY, THE INFUSION SETS WERE NOT USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY, NOR WAS THERE ANY STRESS OR PULL ON THE TUBING. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 188 MG/DL. FURTHER, COMPLAINT INVESTIGATION WAS PERFORMED ON THE RETURNED USED DEVICE (1 TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED BECAUSE IT WAS NOT PROPERLY ASSEMBLED TO THE CONNECTOR. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443874 ↗