Eversense E3 Smart Transmitter Kit FG-5900-01-001Recalls & 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
Quick summary
This Eversense E3 glucose sensor is an implanted continuous glucose monitor. The 79 reports mostly describe glucose readings that did not match blood sugar, triggering false low alerts and sometimes leading to hypoglycemia or hyperglycemia events, with 76 injuries and no deaths. There are no recalls for this device. Reports dropped sharply, from 6 in the prior 12 months to 0 in the last 12 months.
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
- 79
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00817491022912), received between Apr 12, 2022 and Mar 2, 2025 — classified as 76 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Imprecision” (67 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
- Imprecision67
- Adverse Event Without Identified Device or Use Problem6
- Calibration Problem2
- Excessive Heating1
- Fire1
- Insufficient Device Problem Information1
- Unintended Electrical Shock1
- Use of Device Problem1
Patient problems
- Hypoglycemia56
- Hyperglycemia12
- No Clinical Signs, Symptoms or Conditions4
- Hemorrhage/Blood Loss/Bleeding3
- Elevated Ketones/ Diabetic Ketoacidosis2
- Nausea2
- Shaking/Tremors2
- Asthma1
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2025Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A HIGH GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: DATE: (B)(6) 2025 - TIME: 4:38 PM WHERE SG: 152 MG/DL - BG: 337 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT: DATE: (B)(6) 2025 - TIME: 4:38 PM - SG: 152 MG/DL - BG: 337 MG/DL (CONFIRMED VIA FINGERSTICK). 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 BEING ASSISTED BY HIS WIFE WITH 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 21501309 ↗InjuryFeb 21, 2025Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON 22 JAN 2025 WHERE USER'S SG WAS OUT OF RANGE AND BG WAS 206 MG/DL.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 9:11 AM, WHEN THE SG WAS AT 42 MG/DL. PRIOR TO THAT, THERE WAS NO SG DATA BETWEEN 8:45 AM CT TO 9:11 AM CT BECAUSE IT WAS OUT OF RANGE, AND BEFORE THAT THE USER HAD BEEN RECEIVING LOW GLUCOSE ALERTS EVERY 15 MINUTES.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND DIDN'T NEED TO TREAT HIMSELF BECAUSE IT WASN'T A REAL LOW GLUCOSE EVENT, WHICH THE USER CONFIRMED BY CHECKING HIS BG AT THE TIME.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 21439044 ↗InjuryFeb 8, 2025Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED DIABETIC KETOACIDOSIS BETWEEN 7:30 PM AND 8:30 PM ON (B)(6) 2025.THE USER LOST CONSCIOUSNESS, BECAME UNRESPONSIVE, AND WAS TRANSPORTED TO A HOSPITAL BY AMBULANCE FOR EMERGENCY TREATMENT. THE USER REPORTED ON (B)(6) 2025, BETWEEN 7:30PM 8:30PM, SG WAS 178MG/DL AND BG WAS 1000MG/DL.AFTER DMS REVIEW, ON (B)(6) 2025, BETWEEN 7:30PM 8:30PM SG DID NOT GO ABOVE 174MG/DL AND NO BG WAS ENTERED AT THE TIME OF THE EVENT. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW/HIGH GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT PAST THE ALERT LEVEL. THE USER RECEIVED INSULIN DRIPS AND POTASSIUM AS TREATMENT AT THE HOSPITAL. THE USER WAS PRESCRIBED INSULIN AS MEDICATION.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 21340548 ↗InjuryFeb 8, 2025Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED HYPOGLYCEMIC EVENT ON (B)(6) 2024 WHERE USER'S SG WAS 63 MG/DL AND BG WAS 83 MG/DL.AFTER DMS REVIEWS THE VALUES OF BG AND SG WERE CONFIMED AND USER RECEIVED LOW GLUCOSE ALERT ON (B)(6)2025 3:36 AM.THE USER DID NOT TREAT AS HE MENTIONED THAT HIS BG WAS FINE AT THE TIME OF EVENT.THE USER WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.
Patient problems: Hypoglycemia; No Clinical Signs, Symptoms or Conditions
MAUDE report 21340538 ↗InjuryDec 7, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2024 AT 03:16 PM WHERE SG WAS 62MG/DL.AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT AND WE CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 3:16 PM EST, WHEN THE SG WAS AT 62MG/DL.USER DIDN'T SEEK FOR MEDICAL TREATMENT AS HE STATED HE WAS NOT HAVING A LOW.USER'S HCP IS AWARE OF THE EVENT, NO MEDICATION WAS PRESCRIBED.
Patient problems: Hypoglycemia; No Clinical Signs, Symptoms or Conditions
MAUDE report 20873906 ↗InjuryNov 24, 2024Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED AN EVENT WHERE THE SYSTEM TRIGGERED A FALSE LOW GLUCOSE ALERT WHEN THE BG WAS 84 MG/DL AND SG WAS 48 MG/DL AT 10 AM ON (B)(6) 2024.A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) DATA CONFIRMED THAT THE SG VALUE WAS 48 MG/DL AND NO BG WAS ENTERED IN THE SYSTEM.A REVIEW OF THE ALERT HISTORY REVEALED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 09:58 AM. USER DIDN'T SEEK FOR MEDICAL TREATMENT AND MENTIONED THAT HE WAS NOT HAVING A LOW GLUCOSE EVENT.
Patient problems: Hypoglycemia
MAUDE report 20768406 ↗InjuryOct 24, 2024Imprecision; Imprecision
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIA ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY. THE USER REPORTED ON (B)(6) 2024, AROUND 11:00 PM THAT THEIR SG WAS 55 MG/DL AND BG WAS 127 MG/DL. PER DMS, THE SG AND BG VALUES WERE CONFIRMED AND USER RECEIVED A LOW GLUCOSE ALERT ON (B)(6) 2024, AT 11:36 PM.
Patient problems: Hypoglycemia
MAUDE report 20529732 ↗InjuryOct 11, 2024Imprecision; Imprecision
ON SEPTEMBER 12, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT WITH NO ALERT FROM THE SYSTEM.
Patient problems: Hypoglycemia
MAUDE report 20434210 ↗InjuryOct 10, 2024Imprecision; Imprecision
ON SEPTEMBER 10, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIA ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY. THE USER REPORTED ON 9/9/24 AROUND 7:00 PM THAT THEIR SG WAS 49 MG/DL AND BG WAS100 MG/DL. PER DMS, THE SG AT 7:42PM WAS CONFIRMED BUT THE USER'S BG WAS NOT ENTERED IN THE SYSTEM. THE USER RECEIVED A LOW GLUCOSE ALERT ON (B)(6) 2024, AT 7:42 PM.
Patient problems: Hypoglycemia
MAUDE report 20425008 ↗InjurySep 24, 2024Imprecision; Imprecision
ON AUGUST 25, 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT WITH NO ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY.
Patient problems: Hyperglycemia
MAUDE report 20296017 ↗InjurySep 11, 2024Imprecision; Imprecision
ON AUGUST 12, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED TWO EVENTS ON (B)(6) 2024. THE USER BLACKED OUT IN THE MORNING AROUND 10:17AM, AND AT NIGHT ON THE SAME DAY, THE USER'S LEGS WERE GIVING UP. THE USER DID NOT TAKE ANY BG MEASUREMENT DURING THESE TWO EVENTS TO SEE IF SHE WAS HAVING A LOW GLUCOSE EVENT.
Patient problems: Loss of consciousness; Muscle Weakness/Atrophy
MAUDE report 20195491 ↗InjurySep 10, 2024Imprecision; Imprecision
ON AUGUST 12, 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED TWO SEIZURES ONE AFTER THE OTHER DUE TO LOW GLUCOSE, WITH BLOOD COMING OUT OF HER MOUTH, WHICH LED TO THE AMBULANCE BEING CALLED. SUGAR WATER WAS GIVEN AS TREATMENT AT THE HOSPITAL, BUT THERE WAS NO MEDICATION PRESCRIBED.
Patient problems: Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; Hypoglycemia
MAUDE report 20186983 ↗MalfunctionSep 6, 2024Fire; Excessive Heating; Fire; Excessive Heating
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER'S TRANSMITTER WAS BURNED AFTER PLUGGING IN THE CRADLE AND PUTTING THE TRANSMITTER ON THE CHARGER. THE CHARGING CRADLE BEGAN TO SMOKE AND SPARK WHICH STARTED A FIRE, CAUSING THE TRANSMITTER AND CHARGING COMPONENTS TO BE BURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164410 ↗InjurySep 3, 2024Imprecision; Imprecision
ON AUGUST 3, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT WITH NO ALERT FROM THE SYSTEM.
Patient problems: Hyperglycemia
MAUDE report 20131162 ↗InjuryJul 3, 2024Imprecision; Imprecision
ON JUNE 5, 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 DRINKING APPLE JUICE.
Patient problems: Hypoglycemia
MAUDE report 19670355 ↗InjuryJun 6, 2024Imprecision; Imprecision
ON 08 MAY 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE . USER REPORTS A LOW GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: 7-MAY-2024 BETWEEN 10:00 PM - 11:00 PM CT / SG NOT AVAILABLE - BG 48 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT: 7-MAY-2024 BETWEEN 10:00 PM - 11:00 PM CT / SG NOT AVAILABLE - BG NOT ENTERED THE USER DIDN'T HAVE GLUCOSE VALUES AVAILABLE ON THAT PERIOD OF TIME BECAUSE SHE HAD PREVIOUSLY RECEIVED A CALIBRATION PAST DUE ALERT AT 6:37 AM CT, AND LATER A CALIBRATION EXPIRED ALERT AT 10:08 PM CT, THEREFORE LOW GLUCOSE ALERTS WEREN'T AVAILABLE EITHER.USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY TAKING A SHOT OF INSULIN, EATING AND WAITING AROUND 15 MINUTES. USER'S HCP ISN'T AWARE OF THE EVENT, USER WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.
Patient problems: Hypoglycemia
MAUDE report 19476033 ↗InjuryMay 24, 2024Imprecision; Imprecision
ON APRIL 25, 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT THAT LED TO A HOSPITAL STAY.
Patient problems: Hyperglycemia
MAUDE report 19397637 ↗InjuryMay 10, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED A HYPOGLYCEMIC EVENT WITH NO ALERT FROM THE SYSTEM DUE TO INACCURACY IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 19293982 ↗InjuryApr 5, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED A HYPOGLYCEMIC EVENT WITH NO ALERT FROM THE SYSTEM DUE TO INACCURACY IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 19056292 ↗InjuryMar 21, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED A HYPOGLYCEMIC EVENT WITH NO ALERT FROM THE SYSTEM DUE TO INACCURACY IN SENSOR READINGS. THE USER REPORTED SG OF 97 MG/DL AND BG OF 57 MG/DL WHICH WAS CONFIRMED AFTER DMS REVIEW.
Patient problems: Hypoglycemia
MAUDE report 18947367 ↗InjuryMar 5, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF HYPOGLYCEMIC EVENT DUE TO INACCURACIES IN SENSOR READINGS AND THE SYSTEM DID NOT ALERT THE USER.
Patient problems: Hypoglycemia
MAUDE report 18841936 ↗MalfunctionFeb 1, 2024Unintended Electrical Shock; Unintended Electrical Shock
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER EXPERIENCED A "SHOCK" ON THE INSERTION AREA WHEN WEARING THE TRANSMITTER. THE USER DESCRIBED THE SHOOK AS FEELING, "LIKE STATIC" AND ONLY FELT IT THREE OR FOUR TIMES SINCE THE EVENT HAPPENED WHILE WEARING THE TRANSMITTER.
Patient problems: Electric Shock
MAUDE report 18628661 ↗InjuryDec 4, 2023Imprecision; Imprecision
ON OCTOBER 30, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER VISITED THE INSERTING CLINIC TWO DAYS POST INSERTION BECAUSE THE INSERTION SITE CONTINUED TO BLEED THROUGH THE GAUZE AND BANDAGE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18264070 ↗InjuryDec 1, 2023Imprecision; Imprecision
ON OCTOBER 25, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER REPORTED HYPOGLYCEMIC EVENT WITH NO ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY. USER RESOLVED THE ISSUE BY DRINKING APPLE JUICE.
Patient problems: Hypoglycemia
MAUDE report 18252944 ↗InjuryDec 1, 2023Imprecision; Imprecision
ON OCTOBER 27, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER REPORTED A HYPOGLYCEMIA EVENT WITH NO ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY. THE USER WAS ABLE TO RESOLVE THE ISSUE BY DRINKING JUICE.
Patient problems: Hypoglycemia
MAUDE report 18252859 ↗
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 - Retail FG-5901-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use28 reports
- Eversense E3 Smart Transmitter Kit - Provider Purchase FG-5902-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use20 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.
How reports and recalls are matched · Editorial policy · Report an error on this page