Eversense® Smart Transmitter Kit FG-3300-01-001Recalls & reported problems
Senseonics, Incorporated · Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense 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 Senseonics Eversense Smart Transmitter is part of an implanted glucose monitor. Many of its 208 reports describe inaccurate sensor readings, and many mention low blood sugar (hypoglycemia), while some describe emergency room visits. The reports include 198 injuries and no deaths. 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
- 208
- Deaths reported
- 0
- Injuries reported
- 198
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00817491021441), received between Jan 10, 2019 and Jun 10, 2022 — classified as 198 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Imprecision” (132 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.
Most reported problems
Device problems
- Imprecision132
- Adverse Event Without Identified Device or Use Problem39
- Device Alarm System23
- Electrical /Electronic Property Problem5
- Intermittent Communication Failure4
- Failure to Sense3
- Insufficient Device Problem Information3
- Calibration Problem2
Patient problems
- Hypoglycemia137
- Hyperglycemia55
- Elevated Ketones/ Diabetic Ketoacidosis8
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
- Discomfort2
- Encephalopathy2
- No Code Available2
Recent adverse event reports
The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Imprecision; Imprecision
ON 13 MAY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14653312 ↗InjuryMay 12, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14379459 ↗InjuryMay 6, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14305943 ↗InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 15 APRIL 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER FELL AND WENT TO THE EMERGENCY ROOM.
Patient problems: Fall
MAUDE report 14289509 ↗InjuryMay 4, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 14272898 ↗InjuryMay 3, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14269713 ↗InjuryMay 3, 2022Imprecision; Imprecision
ON 01 APRIL 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER WENT TO THE EMERGENCY ROOM DUE TO AN EPISODE OF LOW GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 14268971 ↗InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 22 FEBRUARY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER PASSED OUT AND WENT TO THE EMERGENCY ROOM DUE TO AN EPISODE OF HIGH GLUCOSE LEVELS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Failure of Implant; Hyperglycemia
MAUDE report 14180820 ↗InjuryApr 21, 2022Imprecision; Imprecision
ON 16 MARCH 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14180305 ↗InjuryApr 12, 2022Imprecision; Imprecision
ON 18 MARCH 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 14086503 ↗InjuryMar 31, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13971972 ↗InjuryMar 28, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 13932552 ↗InjuryMar 23, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13867123 ↗InjuryMar 17, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13795050 ↗InjuryFeb 28, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER STOPPED TAKING INSULIN DUE TO LOW GLUCOSE RESULTS ON TRANSMITTER AND HAD TO GO TO THE EMERGENCY ROOM.
Patient problems: Hyperglycemia
MAUDE report 13620018 ↗InjuryFeb 4, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13459665 ↗InjuryFeb 2, 2022Imprecision; Imprecision
ON JANUARY 21ST 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED FALSE HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 13423061 ↗InjuryJan 27, 2022Imprecision; Imprecision
ON (B)(6) 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED HIGH GLUCOSE SYMPTOMS AND HAD TO GO TO THE DOCTOR'S OFFICE.
Patient problems: Hyperglycemia
MAUDE report 13371418 ↗InjuryJan 20, 2022Imprecision; Imprecision
ON JANUARY 5TH 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13310571 ↗InjuryJan 18, 2022Imprecision; Imprecision
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13287508 ↗InjuryJan 18, 2022Imprecision; Imprecision
ON (B)(6) 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 13285898 ↗InjuryJan 18, 2022Imprecision; Imprecision
ON (B)(6) 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13285641 ↗InjuryJan 8, 2022Imprecision; Imprecision
ON 09 DECEMBER 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED HIGH READING WITH HER GLUCOMETER ( HYPERGLYCEMIA) DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 13200986 ↗InjuryJan 8, 2022Imprecision; Imprecision
ON 09 DECEMBER 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED LOW READINGS WITH HER SENSOR (FALSE HYPOGLYCEMIA) DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13200973 ↗InjuryDec 31, 2021Imprecision; Imprecision
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPERGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hyperglycemia
MAUDE report 13123500 ↗
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 Continuous Glucose Monitor, Implanted, Adjunctive Use devices
- Eversense® Sensor Kit FG-4200-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use742 reports
- Eversense® Sensor Kit FG-4200-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use82 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use34 reports
- Eversense® Smart Transmsitter Kit - Retail FG-3301-01-001Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use8 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use3 reports
- Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear FG-6403-01-300Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, 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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