Eversense 365 Sensor Kit (Retail) FG-7501-00-301Recalls & 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 sensor kit is an implanted continuous glucose monitor sensor. Of its 173 reports, 145 describe malfunctions, most often imprecise glucose readings, and 28 are filed as injuries; a few describe skin infections and blood sugar highs or lows. The reports mention no deaths, and no recalls name this device. Reports rose sharply over the past 12 months, with 135 compared with 38 in the year before.
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
- 171
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00817491024299), received between Jan 2, 2025 and Sep 29, 2026 — classified as 28 injuries, 143 malfunctions.
The most frequently reported specific device problem is “Imprecision” (133 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
- Imprecision133
- Adverse Event Without Identified Device or Use Problem17
- Output Problem9
- Communication or Transmission Problem4
- Premature End-of-Life Indicator4
- Difficult to Remove3
- Insufficient Device Problem Information1
- Wireless Communication Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions148
- Skin Infection8
- Hyperglycemia4
- Hemorrhage/Blood Loss/Bleeding3
- Hypoglycemia3
- Fluid Discharge2
- Impaired Healing2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938638 ↗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 50927113 ↗MalfunctionAug 25, 2026Output Problem
On 29 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 50423018 ↗MalfunctionAug 6, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165781 ↗MalfunctionAug 5, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149936 ↗MalfunctionAug 5, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149935 ↗MalfunctionAug 4, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133804 ↗MalfunctionAug 4, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133803 ↗MalfunctionJul 31, 2026Imprecision
On (b)(6) 2026 , Senseonics was made aware of an incident where the user reported sensor readings were different from their blood glucometer measurements. Based on the escalation analysis, sensor replacement was deemed necessary and the device was requested for further evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105320 ↗MalfunctionJul 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091025 ↗MalfunctionJul 30, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078137 ↗MalfunctionJul 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071730 ↗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 25709262 ↗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 25679201 ↗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 25661010 ↗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 25661008 ↗MalfunctionJun 25, 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 25630140 ↗MalfunctionJun 25, 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 25630127 ↗MalfunctionJun 24, 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 25604317 ↗MalfunctionJun 17, 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 25540374 ↗MalfunctionJun 17, 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 25540342 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
ON MAY 22, 2026, SENSEONICS WAS MADE AWARE OF A USER'S INFECTION AT THE SENSOR INSERTION SITE. SYMPTOMS INCLUDED SORENESS, TENDERNESS, AND THE FORMATION OF BLISTERS THAT PRODUCED PURULENT DISCHARGE. THE USER ATTEMPTED TO MANAGE THE CONDITION BY PUNCTURING THE BLISTERS WITH A STERILIZED NEEDLE AND EXPRESSING THE FLUID; DURING THIS PROCESS, THE SENSOR WAS UNINTENTIONALLY EXPELLED FROM THE ARM. DATA LATER SHOWED REDUCED ACCURACY PRIOR TO THE EVENT AND CESSATION OF TRANSMISSION CONSISTENT WITH THE SENSOR'S EXPULSION. FOLLOWING THE INCIDENT, SYMPTOMS WERE RESOLVED WITHOUT MEDICAL TREATMENT, AND THE SITE HEALED WITH NORMAL SKIN APPEARANCE. THE USER DID NOT INITIALLY INFORM THEIR HEALTHCARE PROVIDER BUT LATER FOLLOWED UP WITH THEIR ENDOCRINOLOGIST, WHO DID NOT PRESCRIBE ANTIBIOTICS AND PLANNED FURTHER EVALUATION. THE USER DECLINED A REPLACEMENT SENSOR AND OPTED TO CONTINUE USING AN ALTERNATIVE CGM SYSTEM.
Patient problems: Blister; Purulent Discharge; Skin Infection
MAUDE report 25537135 ↗InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, SENSEONICS WAS MADE AWARE OF A USER EXPERIENCING PROLONGED WOUND CLOSURE. THE STERI-STRIPS WERE REMOVED ON (B)(6) 2026, AFTER WHICH THE USER OBSERVED DRAINAGE, REDNESS, AND PAIN AT THE SITE, ALTHOUGH THE SENSOR WAS NOT VISIBLE IN THE INCISION. THE USER'S HEALTHCARE PROVIDER WAS NOT AWARE OF THE ISSUE, AND THE USER WAS ADVISED TO FOLLOW UP FOR FURTHER MEDICAL EVALUATION. DESPITE THE SYMPTOMS, THE DATA MANAGEMENT SYSTEM CONFIRMED THE SYSTEM REMAINS IN USE WITH UP-TO-DATE DATA. AS A RESULT OF THE EVENT, THE USER REQUESTED THE SENSOR BE REMOVED.
Patient problems: Fluid Discharge; Impaired Healing; Pain
MAUDE report 25526991 ↗MalfunctionJun 15, 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 25513532 ↗MalfunctionJun 12, 2026Imprecision
ON (B)(6) 2026, 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 25494195 ↗
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 (Provider Purchase) FG-7502-00-301Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate297 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