Silhouette® Paradigm® MMT-384Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244009035), received between Apr 18, 2019 and Oct 1, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ISSUES WITH THE SITES AND WHEN SHE FINDS A GOOD SITE, IT SEEMED LIKE THE INSULIN WAS NOT BEING ABSORBED. IT WAS STATED THAT SHE ATE PIECE OF TOAST AS BREAKFAST SANDWICH, 30 CARBOHYDRATES FOR LUNCH SANDWICH AND 30 CARBOHYDRATES FOR DINNER. SHE ALSO MENTIONED THAT SHE DID NOT HAD EVEN A HEFTY MEAL A DAY BEFORE HOSPITALIZATION. SUBSEQUENTLY, ON (B)(6) 2019, SHE WAS ADMITTED TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL WAS 659 MG/DL AND WITH 18 UNITS OF INSULIN. DURING HOSPITALIZATION, SHE RECEIVED INSULIN DRIP AND BLOOD GLUCOSE WAS MONITORED HOURLY. THE INFUSION WAS CHANGED ON (B)(6) 2019. DURING HOSPITALIZATION, SHE REMOVED THE SITE AND DISCOVERED THAT THE CANNULA WAS BENT BUT THERE WAS NO ALARM FROM THE PUMP AND HER BLOOD GLUCOSE LEVEL AT THAT TIME WERE ALREADY NORMAL. SHE WAS ADMITTED FOR 2 AND A HALF DAYS. AT THE TIME OF THIS REPORT ((B)(6) 2019), HER BLOOD GLUCOSE LEVEL WAS 499 MG/DL WITH AN ACTIVE INSULIN OF 7.4 UNITS WHICH INCREASED TO 561 MG/DL DURING THE CALL. FURTHER, SHE DELIVERED 4 UNITS OF INSULIN AFTER 15 MINUTES AND HER BLOOD GLUCOSE WAS AT 510 MG/DL. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9138429 ↗
• MalfunctionApr 18, 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 TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN COMING OUT OF TUBING ABOUT 1-2 HOURS AFTER SET CHANGE. THIS ISSUE OCCURRED WITH FOUR INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8530224 ↗