Eversense 365 Smart Transmitter Kit (DME) FG-4000-01-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00817491024237), received between Jan 21, 2025 and Mar 31, 2026 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Imprecision” (21 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Insufficient Device Problem Information

  ON MARCH 2ND, SENSEONICS WAS NOTIFIED THAT A USER HAD BEEN HOSPITALIZED FOR SURGERY. CUSTOMER CARE ATTEMPTED MULTIPLE FOLLOW-UP CONTACTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOSPITALIZATION; HOWEVER, THE USER COULD NOT BE REACHED DESPITE REPEATED OUTREACH. NO FURTHER DETAILS ABOUT THE HOSPITALIZATION COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 24750448 ↗
• MalfunctionFeb 18, 2026Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.AN RMA WAS AUTHORIZED FOR RETURN OF TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384760 ↗
• MalfunctionFeb 17, 2026Electrical /Electronic Property Problem; Patient Device Interaction Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED FEELING SENSATION OF ELECTRIC SHOCKS FROM THE TRANSMITTER. THE USER DID NOT REPORT ANY PATIENT HARM OR ADVERSE EVENT RESULTING FROM THIS ISSUE. AN RMA WAS AUTHORIZED FOR RETURN OF TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Undesired Nerve Stimulation

  MAUDE report 24373639 ↗
• MalfunctionFeb 17, 2026Environmental Compatibility Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE TOP PORTION OF HIS TRANSMITTER APPEARED TO BE MELTING. THE USER STATED THAT THEY WERE REPEATEDLY EXPOSED TO HIGH-TEMPERATURE KITCHEN EQUIPMENT AND SUBSEQUENTLY OBSERVED CRACKING AND APPARENT MELTING AT THE TOP OF THE TRANSMITTER. THE USER DID NOT REPORT ANY PATIENT HARM OR ADVERSE EVENT. AN RMA WAS AUTHORIZED FOR THE RETURN OF THE TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373591 ↗
• MalfunctionFeb 6, 2026Temperature Problem; Excessive Heating

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE TRANSMITTER FELT WARM TO THE TOUCH AND THAT SHE COULD FEEL WARMTH ON HER ARM WHILE WEARING IT; THE USER WAS INSTRUCTED TO STOP USING THE TRANSMITTER, AND AN RMA WAS ISSUED FOR RETURN OF THE TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284881 ↗
• InjuryJan 9, 2026Imprecision; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED GOING TO THE HOSPITAL DUE TO A POSSIBLE DIABETIC KETOACIDOSIS (DKA) EVENT. ACCORDING TO THE USER, THE ELEVATED GLUCOSE LEVELS MAY HAVE BEEN RELATED TO A BAD PUMP SITE OR POSSIBLE FOOD POISONING. THE USER STATED THAT ALL SUPPLIES WERE CHANGED, INCLUDING FRESH INSULIN, INFUSION SITE, AND TUBING. THE USER REPORTED BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL SINCE APPROXIMATELY 1:30 AM ON (B)(6) 2025. PER LABORATORY RESULTS SHARED BY THE USER, BG WAS 324 MG/DL, WHILE THE EVERSENSE SYSTEM SHOWED AN SG OF 255 MG/DL. THE USER LATER PROVIDED AN UPDATE INDICATING THAT THE EVENT WAS NOT DKA. THE USER REPORTED THAT SHE WAS DISCHARGED AND RECEIVED FLUIDS, AND THAT SG AND BG VALUES WERE WITHIN 5 MG/DL OF EACH OTHER.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 24016836 ↗
• MalfunctionDec 22, 2025Battery Problem; Battery Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED EXPERIENCING AN EVENT OF TRANSMITTER OVERHEATING AND DECIDED TO STOP WEARING THE TRANSMITTER AS OF 11/19, AS IT WAS NOT FUNCTIONING PROPERLY. AN RMA WAS AUTHORIZED FOR RETURN OF SENSOR FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861459 ↗
• MalfunctionNov 4, 2025Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE TRANSMITTER MELTED AFTER BEING CONNECTED TO A CHARGER WHILE IN EUROPE. BASED ON THE REVIEW OF NOTES, PHOTOS, AND DMS DATA, THE TRANSMITTER WAS FOUND TO BE DAMAGED AND NO LONGER USABLE. AN RMA WAS AUTHORIZED FOR THE RETURN OF THE TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472950 ↗
• MalfunctionSep 27, 2025Battery Problem; Battery Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE TRANSMITTER FELT UNUSUALLY HOT TO THE TOUCH. AN RMA WAS CREATED FOR THE RETURN OF THE TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163369 ↗
• MalfunctionSep 23, 2025Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT IN WHICH THE USER REPORTED THAT THE TRANSMITTER BECAME EXTREMELY HOT. A REVIEW OF DMS INDICATED THAT THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2025 DUE TO THIS ISSUE. AN RMA WAS AUTHORIZED FOR THE RETURN OF THE TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23129798 ↗
• MalfunctionAug 7, 2025Imprecision; Imprecision

  ON 08 JULY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. AN RMA WAS AUTHORIZED FOR RETURN OF TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742375 ↗
• MalfunctionJul 31, 2025Imprecision; Imprecision

  ON 01 JULY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. AN RMA WAS AUTHORIZED FOR RETURN OF TRANSMITTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683534 ↗
• MalfunctionJul 21, 2025Imprecision; Imprecision

  ON 13 MAY 2025,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555217 ↗
• MalfunctionJul 21, 2025Imprecision; Imprecision

  ON 01 MAY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553720 ↗
• MalfunctionJul 20, 2025Imprecision; Imprecision

  ON 01 MAY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552556 ↗
• MalfunctionMay 14, 2025Imprecision; Imprecision

  ON 20 FEB 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022754 ↗
• MalfunctionMay 14, 2025Imprecision; Imprecision

  ON (B)(6) 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019763 ↗
• MalfunctionMay 14, 2025Imprecision; Imprecision

  ON 18 FEB 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019555 ↗
• MalfunctionMay 14, 2025Imprecision; Imprecision

  ON (B)(6) 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018522 ↗
• InjuryMay 5, 2025Imprecision; Imprecision

  ON 05 APRIL 2025,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A HIGH GLUCOSE EVENT ON 4-APR-2025 AT 4:00 PM WHERE USER'S SG WAS 80 MG/DL AND BG WAS 547 MG/DL.AFTER DMS REVIEW, WE CONFIRMED THAT ON (B)(6) 2025 AT 4:00 PM WHERE USER'S SG WAS 64 MG/DL AND BG WAS NOT ENTERED.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A HIGH GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT ABOVE THE ALERT LEVEL.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND DIDN'T TREAT HIMSELF AND WAITED FOR HIS GLUCOSE TO GO DOWN NATURALLY, AS THE AUTHORIZED REPRESENTATIVE EXPLAINED DURING THE LATEST INTERACTION THAT USER WAS AFRAID OF "CRASHING OUT" IF USER TREATED HIMSELF WITH INSULIN WITH HIS BG AT THAT LEVEL.THE USER'S HCP ISN'T AWARE OF THE EVENT AND WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

  Patient problems: Hyperglycemia

  MAUDE report 21965239 ↗
• InjuryMay 1, 2025Imprecision; Imprecision

  ON 01 APRIL 2025, USER REPORTED A HIGH GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: DATE: (B)(6) 2025, TIME: 6:10 PM EST SG: 200 MG/DL BG: 387 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT: DATE: (B)(6) 2025, TIME: 6:10 PM EST SG: 200 MG/DL AT 6:09PM EST BG: 387 MG/DL (AVAILABLE IN DMS). AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A HIGH GLUCOSE ALERT AT THE TIME OF THE EVENT BECAUSE THE SG NEVER WENT ABOVE THE ALERT LEVEL.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY ADMINISTERING INSULIN.THE USER'S HCP ISN'T AWARE OF THE EVENT AND WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

  Patient problems: Hyperglycemia

  MAUDE report 21947086 ↗
• InjuryFeb 19, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2025 AT 01:24 AM,BG WAS 67 MG/DL AND SG WAS 53 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 1:12 AM MT, WHEN THE SG WAS AT 60 MG/DL. THE USER DIDN'T HAVE A LOW GLUCOSE EVENT SO HE DIDN'T TREAT HIMSELF, BUT HE MENTIONED THAT HE EATS SMALL AMOUNTS OF CARBS BEFORE SLEEPING TO KEEP HIS BG ABOVE LEVELS. THE USER'S HCP ISN'T AWARE OF THE EVENT AND WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

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

  MAUDE report 21417802 ↗
• MalfunctionFeb 12, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE REPORTED INACCURACY IN SENSOR READINGS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366786 ↗
• InjuryFeb 11, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED RECEIVING LOW GLUCOSE ALERTS ON HIS SYSTEM DUE TO INACCURACY IN SENSOR READINGS WHEN THE USER'S BLOOD GLUCOSE WAS NOT LOW. AFTER REVIEWING THE USER'S INFORMATION WITH THE DATA AVAILABLE IN DMS, WE CONFIRMED ONLY ONE INSTANCE WHERE THE USER RECEIVED A LOW GLUCOSE ALERT, ON (B)(6) 2025 AT 4:58 AM WHEN THE SG WAS AT 65 MG/DL.

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

  MAUDE report 21355674 ↗
• InjuryFeb 8, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2025 BETWEEN 02:00 AM TO 04:00 PM WHERE USER'S SG WAS 57 MG/DL AND BG WAS 120 MG/DL. SINCE USER COULDN'T PROVIDE A SPECIFIC DATE OF EVENT, THE FOLLOWING INFORMATION WAS CONFIRMED IN DMS USING THE INFORMATION VALUE PROVIDED, WHERE SG WAS 57 MG/DL CONFIRMED ON (B)(6)2025 AT 2:35 AM AND BG 120 MG/DL WASN'T ENTERED INTO THE SYSTEM. THE USER RECEIVED THE FIRST LOW GLUCOSE ALERT AT 2:10 AM, WHEN THE SG WAS AT 58 MG/DL, AND KEPT RECEIVING ALERTS EVERY 15 MINUTES. THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BECAUSE HE HAD NO SYMPTOMS OF A LOW GLUCOSE EVENT. THE USER WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

  Patient problems: Hypoglycemia

  MAUDE report 21340543 ↗