Silhouette® Paradigm® MMT-381600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244008564), received between Jan 11, 2019 and Jan 30, 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER:(B)(4). A MALE DIABETIC PATIENT WAS HOSPITALIZED ON SATURDAY (B)(6) 2018 AT 3:30 AM DUE TO HYPOGLYCEMIA AND DIABETIC COMA. LOW BLOOD GLUCOSE LEVEL OF 1.7 MMOL/L AT TIME OF EVENT. THE PATIENT REPORTED THAT HE WAS IN THE HOSPITAL FOR FEW HOURS AND WAS DISCHARGED ON THE SAME DAY. IT WAS STATED THAT THE PATIENT DID NOT HAVE A SENSOR AND HE FELL IN TO DIABETIC COMA IN THE NIGHT AND WENT TO THE HOSPITAL. THE PATIENT REPORTED THAT BEFORE GOING TO SLEEP HE NOTICED A BUMP ON HIS SKIN AND HE THOUGHT THAT THE BUMP WAS DUE TO INSULIN STACKING. IT WAS REPORTED THAT THE PATIENT CHANGED THE INFUSION SET AND SITE OF INSERTION AND GAVE HIMSELF A CORRECTION. THE PATIENT REPORTED THAT HE WENT TO SLEEP AND CHECKED HIS BLOOD GLUCOSE JUST BEFORE GOING TO BED. IT WAS STATED THAT HIS WIFE NOTICED THAT HE WAS SWEATY AND GAVE HIM ORANGE JUICE AND SUGAR. IT WAS REPORTED THAT THE AMBULANCE WAS CALLED OUT AND HE WAS GIVEN GLUCAGON INJECTIONS TO BRING HIS BLOOD GLUCOSE BACK TO NORMAL. IT WAS REPORTED THAT THE CAUSE OF HOSPITALIZATION PER HEALTH CARE PROFESSIONAL WAS LOW BLOOD GLUCOSE. IT WAS REPORTED THAT THE PATIENT WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION AND

  Patient problems: Coma; Hypoglycemia

  MAUDE report 8288254 ↗
• MalfunctionJan 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET TUBING GOT DETACHED WHILE SHOPPING. REPORTEDLY, THE LOCATION OF DETACHMENT WAS AT THE CONNECTOR. THE SITE LOCATION WAS ABDOMEN AND THE PUMP WAS WORN ON BELT. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE INFUSION HAD BEEN IN USE FOR FOUR DAYS. ALSO, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WASN'T DROPPED WITH THE SET CONNECTED TO THE BODY. THE PATIENT HAD FACED THE SAME ISSUE EARLIER AS WELL, TWO TIMES BUT REALIZED IT TWO HOURS LATER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238776 ↗