Eversense 365 Sensor Kit (Provider Purchase) FG-7502-00-301Recalls & reported problems
Senseonics, Incorporated · Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder. · Class 2 · Implant
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Senseonics Eversense 365 is an implanted continuous glucose monitoring sensor. Most of its 299 reports describe readings that differ from blood glucose meter measurements. The reports include no deaths and 46 injuries, and a few mention low or high blood sugar or skin infections. Reports rose from 59 in the 12 months before to 240 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 297
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00817491024305), received between Jan 15, 2025 and Sep 30, 2026 — classified as 44 injuries, 253 malfunctions.
The most frequently reported specific device problem is “Imprecision” (207 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.
Reports received per month
Most reported problems
Device problems
- Imprecision207
- Output Problem34
- Adverse Event Without Identified Device or Use Problem29
- Communication or Transmission Problem16
- Premature End-of-Life Indicator6
- Insufficient Device Problem Information5
- Unable to Obtain Readings3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions257
- Skin Infection10
- Hypoglycemia8
- Hyperglycemia6
- Insufficient Information5
- Skin Inflammation/ Irritation3
- Swelling/ Edema2
- Back pain1
Recent adverse event reports
The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952853 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938636 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938635 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938634 ↗MalfunctionSep 29, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927117 ↗MalfunctionSep 29, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927114 ↗MalfunctionAug 27, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465813 ↗MalfunctionAug 25, 2026Output Problem
On 26 Jul 2026, Senseonics was made aware of an incident where user received a glucose suspend alert which resulted in an early sensor removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50423015 ↗MalfunctionAug 6, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165776 ↗MalfunctionAug 5, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149941 ↗MalfunctionAug 5, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149924 ↗MalfunctionAug 4, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133807 ↗MalfunctionAug 4, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133806 ↗MalfunctionAug 4, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124928 ↗MalfunctionAug 3, 2026Imprecision
On August 13th 2025, Senseonics was made aware of an incident where user experienced sensor inaccuracy. No Injury or Medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114583 ↗MalfunctionJul 31, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105308 ↗MalfunctionJul 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078136 ↗MalfunctionJul 30, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078129 ↗MalfunctionJul 30, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078128 ↗MalfunctionJul 27, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046392 ↗MalfunctionJul 3, 2026Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM BLOOD GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709255 ↗InjuryJul 1, 2026Imprecision
ON MAY 12, 2026, SENSEONICS WAS MADE AWARE OF A USER'S HYPOGLYCEMIC EVENT. THE USER REPORTED A SENSOR GLUCOSE READING OF 104 MG/DL AND CONFIRMED BLOOD GLUCOSE OF 38 MG/DL, WHICH DID NOT TRIGGER ALERTS BECAUSE THE SENSOR VALUE STAYED ABOVE THE LOW ALERT THRESHOLD. THE USER WAS HOSPITALIZED, TREATED WITH SUGAR, IV FLUIDS, AND ANTIBIOTICS, AND STABILIZED BEFORE LOSING CONSCIOUSNESS. THE USER'S HEALTHCARE PROVIDER WAS INFORMED, AND THE USER HAS SINCE REPORTED FEELING BETTER AND CONTINUES TO USE THE SYSTEM WITH CURRENT DATA.
Patient problems: Hypoglycemia
MAUDE report 25681974 ↗MalfunctionJul 1, 2026Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM BLOOD GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679189 ↗MalfunctionJun 30, 2026Imprecision
ON APRIL 2, 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR INACCURACY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673816 ↗MalfunctionJun 29, 2026Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM BLOOD GLUCOMETER MEASUREMENTS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661015 ↗
Other Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate devices
- Eversense 365 Sensor Kit (DME) FG-7500-00-301Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate1,915 reports
- Eversense 365 Sensor Kit (Retail) FG-7501-00-301Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate171 reports
- Eversense 365 Smart Transmitter Kit (DME) FG-4000-01-001Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate29 reports
- Eversense 365 Smart Transmitter Kit (Retail) FG-4001-01-001Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page