Silhouette® Paradigm® MMT-377Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05705244009332), received between Jan 31, 2018 and Apr 3, 2020 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE EXPERIENCED DIABETIC KETOACIDOSIS RELATED TO AN INCIDENT WHERE HER TUBING WAS LEAKING AS THE INFUSION SET'S TUBING COMING APART FROM THE TUBING CONNECTOR. REPORTEDLY, THE PATIENT DID NOT GO TO THE HOSPITAL, BUT SELF-DIAGNOSED THE DIABETIC KETOACIDOSIS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9919498 ↗
• MalfunctionNov 27, 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 THE INFUSION SET'S TUBING CAME OUT OF THE SITE AND THE QUICK RELEASE STAYED ATTACHED, WHILE SLEEPING. REPORTEDLY, THE PATIENT TOOK MANUAL INJECTION TO BRING DOWN THE BLOOD GLUCOSE LEVEL. THE SITE LOCATION WAS THE PATIENT'S RIGHT SIDE AND THE PUMP WAS IN THE RIGHT POCKET. THE INFUSION HAD BEEN USED FOR TWO DAYS AND THEY WERE STORED IN THE BEDROOM DRAWER. 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 Known Impact Or Consequence To Patient

  MAUDE report 9382554 ↗
• 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 A FEW DAYS BEFORE THIS REPORT, HE HAD JUST SHOWERED IN THE MORNING AND THEN, IT WAS FOUND THAT THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE. THE SITE LOCATION WAS LEFT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE LEFT SIDE IN RELATION TO THE SITE. THE INFUSION HAD BEEN IN USE FOR ABOUT 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 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784196 ↗
• MalfunctionApr 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE TUBING ITSELF POPPED OUT OF THE CLIP (QUICK RELEASE) AND WAS HANGING THERE. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AT THE TIME. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485937 ↗
• MalfunctionApr 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHILE SLEEPING, THE INFUSION SET'S TUBING WHICH CONNECTS THE SET TO THE QUICK RELEASE HAD COME OFF AND THE SITE WAS DISCONNECTED. REPORTEDLY, THIS WAS OBSERVED WHEN THE PATIENT WOKE UP ON THE MORNING OF THIS REPORT, FELT SICK AND CHECKED HIS BLOOD GLUCOSE WAS 346 MG/DL. THE SITE WAS LOWER LEFT ABDOMEN AND THE PUMP WAS ON HIS LEFT HIP IN PAJAMA SHORTS. THE INFUSION WAS USED SINCE LAST NIGHT. THE INFUSIONS WERE STORED IN A CONTAINER. THE PATIENT WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. THE PATIENT CHANGED THE SET, AND HIS BLOOD GLUCOSE CAME DOWN TO 86 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8468214 ↗
• MalfunctionFeb 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET TUBING WAS COMING OUT OF THE TUGGING CONNECTOR AND HAD HIGH BLOOD GLUCOSE LEVEL. THE LOCATION OF DETACHMENT WAS AT THE TUBING CONNECTOR. THE SITE LOCATION WAS AT THE STOMACH. THE INFUSION HAD BEEN IN USE FOR 1 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8319392 ↗
• MalfunctionFeb 7, 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 TUBE GOT DISCONNECTED FROM THE TUBING CONNECTOR WHILE SLEEPING. THE SITE WAS ABDOMEN AND THE PATIENT USED LONG TUBING/ RIGHT NEXT TO SENSOR (PUMP). THE LOCATION OF DETACHMENT WAS AT TUBING CONNECTOR. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT STATED THERE WAS NOT ANY 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 8314038 ↗
• DeathJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4). A DIABETIC PATIENT ON PUMP THERAPY PASSED AWAY. DATE UNKNOWN. THE INCIDENT WAS REPORTED BY A FRIEND OF PATIENT WHEN SHE CALLED TO ASK IF PATIENT'S INFUSION SETS (LOT NUMBER) WERE APART OF THE RECALL INQUIRED WHAT LED UP TO THE COMPLAINT. SHE WAS ADVISED THAT THE LOT NUMBER WAS NOT A PART OF RECALL. SHE MENTIONED THAT SHE DID NOT HAVE THE DETAILS SURROUNDING THE PATIENT'S DEATH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Death

  MAUDE report 7230158 ↗