Eversense 365 Sensor Kit (DME) FG-7500-00-301Recalls & 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 glucose sensor that reads blood sugar under the skin. Many reports describe sensor readings that differ from blood glucose meter results, and some mention skin infections or irritation. The records include 1,941 reports, 406 injuries and no deaths, and no recalls name this device. Reports rose from 616 in the year before to 1,324 in the most recent year.
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
- 1,915
- Deaths reported
- 0
- Injuries reported
- 393
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,915 adverse event reports that list this exact device (DI 00817491024282), received between Oct 26, 2024 and Sep 29, 2026 — classified as 393 injuries, 1,522 malfunctions.
The most frequently reported specific device problem is “Imprecision” (1,359 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
- Imprecision1,359
- Adverse Event Without Identified Device or Use Problem240
- Output Problem128
- Communication or Transmission Problem80
- Premature End-of-Life Indicator56
- Difficult to Remove29
- Unable to Obtain Readings23
- Connection Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions1,596
- Skin Infection65
- Hypoglycemia53
- Hyperglycemia50
- Skin Inflammation/ Irritation34
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available21
- Insufficient Information21
- Pain15
Recent adverse event reports
The 25 most recent of 1,915 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 50938641 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938640 ↗MalfunctionSep 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938639 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938637 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938633 ↗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 50927138 ↗MalfunctionSep 29, 2026Output Problem
On (b)(6) 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 50927137 ↗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 50927136 ↗MalfunctionSep 29, 2026Output Problem
On (b)(6) 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 50927135 ↗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 50927134 ↗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 50927133 ↗MalfunctionSep 29, 2026Output Problem
On 31 Aug 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 50927132 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
On (b)(6) 2026, Senseonics was made aware of an incident where user received a no sensor detected alert which resulted in an early sensor removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927131 ↗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 50927130 ↗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 50927127 ↗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 50927116 ↗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 50927115 ↗MalfunctionSep 28, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925963 ↗MalfunctionSep 28, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925962 ↗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 50465809 ↗MalfunctionAug 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 50423030 ↗MalfunctionAug 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 50423028 ↗MalfunctionAug 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 50423023 ↗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 50423021 ↗MalfunctionAug 17, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289522 ↗
Other Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate devices
- Eversense 365 Sensor Kit (Provider Purchase) FG-7502-00-301Senseonics, Incorporated · Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate297 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