Eversense E3 Smart Transmitter Kit - Retail FG-5901-01-001Recalls & 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 Smart Transmitter Kit is a body-worn continuous glucose monitor that sits on the skin and sends readings to a phone, with charging accessories. The 28 reports mostly describe the sensor reading inaccurately or not alerting users, in many cases during low blood sugar episodes; 27 reports involved injuries and no deaths. One report mentions the transmitter overheating in its charging cradle, producing smoke and melting parts. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00817491022929), received between Sep 25, 2022 and Jan 9, 2025 — classified as 27 injuries, 1 malfunction.
The most frequently reported specific device problem is “Imprecision” (26 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
- Imprecision26
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem1
Patient problems
- Hypoglycemia21
- Hyperglycemia4
- Anxiety1
- Convulsion/Seizure1
- Diarrhea1
- Elevated Ketones/ Diabetic Ketoacidosis1
- Fatigue1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Imprecision; Imprecision
ON 10 DECEMBER 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2024 WHERE SG WAS 133 MG/DL AND BG WAS 65 MG/DL.AFTER DMS REVIEW ON (B)(6) 2024 WHERE SG WAS 119 MG/DL AND BG WAS WAS 65 MG/DL.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL.USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY EATING SOME SNACKS.
Patient problems: Hypoglycemia
MAUDE report 21119086 ↗InjuryJan 5, 2025Imprecision; Imprecision
ON 06 NOVEMBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2024 WHERE SG WAS 119 MG/DL AND BG WAS 58 MG/DL.AFTER DMS REVIEW ON (B)(6) 2024 WHERE SG WAS 119 MG/DL AND BG WAS NOT AVAILABLE IN DMS.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL.USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY EATING SOME SNACKS.
Patient problems: Hypoglycemia
MAUDE report 21076490 ↗InjuryNov 21, 2024Imprecision; Imprecision
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON (B)(6) 2024 AROUND 10 OR 11 AM EST WHERE THE USER'S SG WAS BETWEEN 180MG/DL AND 190 MG/DL USER DID NOT REMEMBER THE BG MEASURE.AFTER DMS REVIEW, WE CAN SEE THAT BETWEEN THE HOURS THAT THE USER MENTIONED THE SG WAS FLUCTUATING BETWEEN A MINIMUM OF 146 MG/DL AND MAXIMUM OF 156 MG/DL, AND THE BG IS NOT AVAILABLE IN DMS.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL.USER DIDN'T SEEK FOR MEDICAL TREATMENT. USER RESOLVED THE EVENT BY DRINKING AN ORANGE JUICE.
Patient problems: Hypoglycemia
MAUDE report 20752215 ↗InjuryNov 2, 2024Imprecision; Imprecision
ON 03 OCTOBER 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER REPORTED EXPERIENCING A LOW GLUCOSE EVENT THAT CAUSED HIM TO BECOME UNCONSCIOUS AND AMBULANCE WAS CALLED.THE ISSUE HAPPENEND ON (B)(6) 2024 AROUND 02:40 PM.THE USER MENTIONED THAT THE SG AT THE TIME OF THE EVENT WAS 70 MG/DL WHILE THE BG WAS 28 MG/DL. A REVIEW OF THE DMS DATA REVEALED THAT THE SG VALUE WAS 79 MG/DL AT 02:40 AM AND BG WAS NOT ENTERED.THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL.THE USER RECEIVED AN IV AS TREATMENT BY THE AMBULANCE. THE USER WASN'T PRESCRIBED MEDICATION.
Patient problems: Hypoglycemia
MAUDE report 20594757 ↗InjuryOct 1, 2024Imprecision; Imprecision
ON (B)(6) 2024 , SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER REPORTED PASSING OUT DUE TO HYPOGLYCEMIA WITH NO ALERT ASSERTED FROM THE SYSTEM.
Patient problems: Hypoglycemia; Syncope/Fainting
MAUDE report 20348415 ↗InjuryNov 19, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF A HYPOGLYCEMIA EVENT WITH NO ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 18166969 ↗InjuryNov 19, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED "NOT REMEMBERING MUCH" FROM 4 HOURS (11AM TO 3PM) OF THE DATE OF EVENT WHEN HE WAS SITTING ALONE AT WORK. THE USER MENTIONED THAT HIS GLUCOSE LEVEL IS USUALLY LOW BEFORE AND AROUND NOON, THOUGH ON THE DATE OF EVENT HE DID NOT CHECK HIS SG AND BG MEASUREMENTS. THE USER TOOK SOME GLUCOSE GEL AROUND 3PM AND DID NOT REQUIRE FURTHER MEDICAL INTERVENTION. THE USER MADE HIS HCP AWARE OF THE EVENT.
Patient problems: Hypoglycemia
MAUDE report 18166967 ↗MalfunctionOct 27, 2023Battery Problem; Battery Problem
ON SEPTEMBER 27, 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE A USER COMPLAINED ABOUT AN OVERHEATING ISSUE WITH TRANSMITTER WHEN IT WAS PLACED IN CHARGING CRADLE, WHICH CAUSED SMOKE COMING FROM THE CRADLE AND MELTING OF THE CRADLE AND TRANSMITTER PINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18024037 ↗InjuryAug 21, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED RECEIVING LOW GLUCOSE ALERT BY THE SYSTEM, BUT HIS BLOOD GLUCOSE LEVEL WAS NORMAL ON HIS BG METER.
Patient problems: Hypoglycemia
MAUDE report 17590832 ↗InjuryAug 21, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED RECEIVING LOW GLUCOSE ALERT BY THE SYSTEM, BUT HIS BLOOD GLUCOSE LEVEL WAS NORMAL ON HIS BG METER.
Patient problems: Hypoglycemia
MAUDE report 17590823 ↗InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON JULY 18, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER HAD TO CALL THE PARAMEDICS DUE TO FEELING REALLY FATIGUED, TIRED, MUSCLE WEAKNESS, AND AN ANXIOUS FEELING AFTER INSERTION ON (B)(6) 2023. THE USER STATED HAVING A PRECONDITION CALLED CONGENITAL ADRENAL HYPOPLASIA AND HAS TO TAKE STEROID THERAPY WHICH CAN SOMETIMES CAUSE SYMPTOMS LIKE HYPOGLYCEMIA.
Patient problems: Anxiety; Fatigue; Muscle Weakness/Atrophy
MAUDE report 17499537 ↗InjuryMay 18, 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 16958961 ↗InjuryMay 18, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED HYPOGLYCEMIA EVENT WITH NO ALERT ASSERTED BY THE SYSTEM DUE TO SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 16958955 ↗InjuryMay 18, 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 AN INACCURACY IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16958942 ↗InjuryMay 12, 2023Imprecision; Imprecision
ON (B)(6) 2023 SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER FELL CAUSING A CHIN LACERATION DUE TO A HYPOGLYCEMIA EVENT.
Patient problems: Hypoglycemia; Laceration(s)
MAUDE report 16924499 ↗InjuryMay 5, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER WAS HOSPITALIZED DUE TO FEELING LETHARGIC, FOLLOWED BY PUKING, DIARRHEA AND KETOACIDOSIS ON (B)(6) 2023. THE USER WAS ADMITTED TO THE ICU BECAUSE OF LOSS OF NEUROLOGICAL CONTROL.
Patient problems: Diarrhea; Elevated Ketones/ Diabetic Ketoacidosis; Movement Disorder
MAUDE report 16881824 ↗InjuryApr 5, 2023Imprecision; Imprecision
ON MARCH 6, 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIC ALERT DUE TO SENSOR INACCURACY.
Patient problems: Hypoglycemia
MAUDE report 16684144 ↗InjuryFeb 17, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPOGLYCEMIC ALERTS DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16396113 ↗InjuryJan 31, 2023Imprecision; Imprecision
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER REPORTED "A SEVERE INSULIN REACTION RESULTING IN SEIZURE" AND "CRASHING."
Patient problems: Convulsion/Seizure; Hyperglycemia
MAUDE report 16274822 ↗InjuryJan 5, 2023Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPOGLYCEMIA DUE INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16108583 ↗InjuryJan 5, 2023Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPOGLYCEMIA DUE INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16102928 ↗InjuryDec 30, 2022Imprecision; Imprecision
ON 02 DECEMBER 2022,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 16079936 ↗InjuryDec 26, 2022Imprecision; Imprecision
ON 26 NOVEMBER 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 16047882 ↗InjuryDec 13, 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 15974693 ↗InjuryDec 10, 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 15956183 ↗
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 - 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.
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