Eversense E3 Smart Transmitter Kit - Provider Purchase FG-5902-01-001Recalls & reported problems
Senseonics, Incorporated · Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card. · Class 3
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00817491022936), received between Nov 17, 2022 and Nov 27, 2024 — classified as 20 injuries.
The most frequently reported specific device problem is “Imprecision” (18 reports).
1 other recall cover devices cleared under the same FDA submission (P160048); they may or may not involve this specific model.
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
- Imprecision18
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Hypoglycemia9
- Hyperglycemia8
- Chills1
- Discomfort1
- Dizziness1
- Fever1
- Muscle Weakness/Atrophy1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2024Imprecision; Imprecision
ON (B)(6) 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED LOW GLUCOSE EVENT ON (B)(6) 2024 WHERE SG WAS 47MG/DL AND BG WAS 93MG/DL.AFTER DMS REVIEW,WE CONFIRMED THAT THE SG WAS 47MG/DL AND BG WAS 93MG/DL AND USER RECEIVED A LOW GLUCOSE ALERT AT 7:54:12 AM, WHEN THE SG WAS AT 47MG/DL.USER DIDN'T SEEK FOR MEDICAL TREATMENT AND STATED THERE WERE NO LOW GLUCOSE SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798418 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON JUNE 11, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER WAS ADMITTED TO ER AND HAVING SYMPTOMS OF WEAKNESS, FEELING DIZZY AND NUMBNESS IN THE LEFT ARM. THE EXAMINING ER DOCTOR SUSPECTED IT WAS DUE TO TRANSIENT ISCHEMIC ATTACK (TIA). THE ADVERSE EVENT WAS NOT RELATED TO THE USE OF THE EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM.
Patient problems: Dizziness; Muscle Weakness/Atrophy; Numbness; Transient Ischemic Attack
MAUDE report 19715033 ↗InjuryMay 23, 2024Imprecision; Imprecision
ON APRIL 24, 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER REPORTED A HYPOGLYCEMIC EVENT WITH NO ALERT FROM THE SYSTEM. THE USER DIDN'T SEEK MEDICAL TREATMENT AND RESOLVED THE EVENT BY TAKING GLUCOSE TABS AND EATING.
Patient problems: Hypoglycemia
MAUDE report 19389024 ↗InjuryDec 18, 2023Imprecision; Imprecision
ON DECEMBER 5, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE AN AMBULANCE WAS CALLED AND THE USER WAS HOSPITALIZED DUE TO A HYPOGLYCEMIA EVENT WITHOUT AN ALERT FROM THE SYSTEM ALLEGEDLY DUE TO SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 18352752 ↗InjuryJun 14, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT DUE TO SENSOR INACCURACY.
Patient problems: Hyperglycemia
MAUDE report 17131286 ↗InjuryJun 14, 2023Imprecision; Imprecision
ON MAY 16, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIA ALERT DUE TO A SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 17131280 ↗InjuryJun 14, 2023Imprecision; Imprecision
ON MAY 17, 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM AS THE SENSOR WAS NOT CONNECTED TO THE TRANSMITTER AT THE TIME OF EVENT.
Patient problems: Hyperglycemia
MAUDE report 17131132 ↗InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON APRIL 10, 2023 SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED AN INFECTION AT THE OLD SENSOR INSERTION SIGHTS WHEN THE AREA BECAME RAISED AND HARD WITH PUS AND BLOOD.
Patient problems: Discomfort; Purulent Discharge; Swelling/ Edema; Unspecified Infection
MAUDE report 16899459 ↗InjuryMay 5, 2023Imprecision; Imprecision
ON (B)(6) 2023,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS AND THE SYSTEM DID NOT ALERT THE USER,
Patient problems: Hyperglycemia
MAUDE report 16878258 ↗InjuryMar 17, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM DUE TO A SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 16562928 ↗InjuryMar 17, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM DUE TO A SENSOR INACCURACY.
Patient problems: Hyperglycemia
MAUDE report 16562921 ↗InjuryMar 10, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM DUE TO A SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 16526861 ↗InjuryMar 1, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIA ALERT DUE TO A SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 16463956 ↗InjuryMar 1, 2023Imprecision; Imprecision
ON (B)96) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM DUE TO A SENSOR INACCURACY.
Patient problems: Chills; Fever; Hypoglycemia; Shaking/Tremors
MAUDE report 16463869 ↗InjuryFeb 6, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA SYMPTOMS.
Patient problems: Hyperglycemia
MAUDE report 16309081 ↗InjuryFeb 4, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA SYMPTOMS DUE TO INACCURACIES IN SENSOR READINGS AND SYSTEM DID NOT ALERT THE USER.
Patient problems: Hyperglycemia
MAUDE report 16301671 ↗InjuryJan 11, 2023Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA SYMPTOMS DUE TO INACCURACIES IN SENSOR READINGS AND SYSTEM DID NOT ALERT THE USER.
Patient problems: Hyperglycemia
MAUDE report 16137824 ↗InjuryDec 20, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED FALSE HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16019926 ↗InjuryNov 28, 2022Imprecision; Imprecision
ON 28 OCTOBER 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER WAS HOSPITALIZED DUE TO A HIGH GLUCOSE EVENT ON (B)(6) 2022.DURING HOSPITALIZATION USER WAS TREATED WITH INSULIN VIA IV, NO MEDICATION WAS PRESCRIBED AFTER THE EVENT. USER CONFIRMED THAT HE'S DOING FINE AND HE IS ALMOST BACK TO NORMAL.
Patient problems: Hyperglycemia
MAUDE report 15870691 ↗InjuryNov 17, 2022Imprecision; Imprecision
ON OCTOBER 17TH 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS AND SYSTEM DID NOT ALTER THE USER.
Patient problems: Hypoglycemia
MAUDE report 15811886 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160048. One submission often covers many models, so check the product and lot details in each record.
- Z-0251-2020 · Sep 18, 2019 · TerminatedEversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Other Sensor, Glucose, Implanted, Non-Adjunctive Use devices
- Eversense E3 Sensor Kit - DME FG-7200-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use334 reports
- Eversense E3 Sensor Kit – Provider Purchase FG-7202-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use90 reports
- Eversense E3 Sensor Kit - Retail FG-7201-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use87 reports
- Eversense E3 Smart Transmitter Kit FG-5900-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use79 reports
- Eversense E3 Smart Transmitter Kit - Retail FG-5901-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use28 reports
- Eversense® Sensor Kit – Provider Purchase FG-4202-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use15 reports
- Eversense® Smart Transmitter Kit – Provider Purchase FG-3302-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use1 report
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.
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