Eversense 365 Smart Transmitter Kit (Retail) FG-4001-01-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817491024244), received between Jan 26, 2025 and Feb 13, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Imprecision” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Imprecision; Imprecision

  ON (B)(6) 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR INACCURACY. THE CUSTOMER WAS EDUCATED ON THE LAG BETWEEN CGM AND BGM READINGS AND ADVISED ENTER ANY ADDITIONAL CALIBRATIONS REQUESTED BY THE SYSTEM. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381824 ↗
• InjuryFeb 7, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF RECEIVING LOW GLUCOSE ALERT ON (B)(6) 2025 WHERE BG WAS 100 MG/DL AND SG WAS 46 MG/DL.AFTER DMS REVIEW,SG WAS 49 MG/DL AT THAT TIME OF EVENT AND NO BG WAS TAKEN.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 08:00 AM.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND DIDN'T TAKE ANY ACTIONS TO SOLVE THE EVENT BECAUSE IT WAS A FALSE LOW EVENT, AND HE HAD NO SYMPTOMS.

  Patient problems: Hypoglycemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339145 ↗
• InjuryJan 26, 2025Imprecision; Imprecision

  ON 27 DECEMBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2024 WHERE SG WAS 45 MG/DL AND BG WAS 120 MG/DL.AFTER DMS REVIEW ON (B)(6) 2024 WHERE SG WAS 43 MG/DL AND BG WAS 120 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 08:10 AM, WHEN THE SG WAS AT 41 MG/DL.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND DIDN'T TAKE ANY ACTIONS TO SOLVE THE EVENT BECAUSE HE CONFIRMED THAT IT WAS A FALSE LOW EVENT AND HE HAD NO SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21238092 ↗
• InjuryJan 26, 2025Imprecision; Imprecision

  ON 27 DECEMBER 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON 22 DECEMBER 2024 WHERE SG WAS 45 MG/DL AND BG WAS 135 MG/DL. AFTER DMS REVIEW ON 27 DECEMBER 2024 WHERE SG WAS 67 MG/DL AND BG WAS 135 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 9:15 AM AS GLUCOSE WAS GOING DOWN, WHEN THE SG WAS AT 61MG/DL. THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND DIDN'T TAKE ANY ACTIONS TO SOLVE THE EVENT BECAUSE HE CONFIRMED THAT IT WAS A FALSE LOW EVENT, AND HE HAD NO SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21238073 ↗