Skip to content

Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-010Recalls & reported problems

Dexcom, Inc. · G7 15 Day US Retail Gov Sensor 1pk · Class 2

Quick summary

This Dexcom G7 sensor is the subject of 1,053 adverse event reports, which mention no deaths and 40 injuries. Most reports describe wireless communication problems and signal loss, along with readings that were too low or too high, and some describe the sensor detaching. Reports began in January 2026. 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
1,527
Deaths reported
0
Injuries reported
60
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,527 adverse event reports that list this exact device (DI 00386270004734), received between Jan 22, 2026 and Sep 30, 2026 — classified as 60 injuries, 1,466 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (968 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 3 reportsMar 2026: 20 reportsApr 2026: 96 reportsMay 2026: 137 reportsJun 2026: 220 reportsJul 2026: 224 reportsAug 2026: 345 reportsSep 2026: 479 reportsOct 2026: 0 reports202420252026479
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Wireless Communication Problem968
  • Low Readings308
  • High Readings98
  • Detachment of Device or Device Component84
  • Appropriate Device Problem Term/Code Not Available18
  • Incorrect, Inadequate or Imprecise Result or Readings16
  • Break11
  • Premature End-of-Life Indicator9

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,079
  • Hyperglycemia313
  • Hypoglycemia94
  • Foreign Body In Patient25
  • Loss of consciousness19
  • Dizziness14
  • Malaise11
  • Nausea11

Recent adverse event reports

The 25 most recent of 1,527 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954986 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954968 ↗
  • MalfunctionSep 30, 2026Low Readings

    Patient problems: Hyperglycemia

    MAUDE report 50954648 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954598 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    Patient problems: Foreign Body In Patient

    MAUDE report 50953620 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50952686 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50952511 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that signal loss occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour within the investigation window. The probable cause was the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951973 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951689 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a No Readings/ Sensor Error/ Brief Sensor Issue occurred. Performance data was reviewed. No Readings/ Sensor Error/ Brief Sensor issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over an hour was found in connection to the reported allegation. The probable cause of the signal loss was determined to be the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951477 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951465 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that No Readings/ Sensor Error/ Brief Sensor Issue occurred. Performance data was reviewed. No Readings/ Sensor Error/ Brief Sensor Issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over one hour was found in connection to the reported allegation. The probable cause of the signal loss could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951116 ↗
  • OtherSep 30, 2026Wireless Communication Problem

    It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950705 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the arm on (b)(6)2026. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950699 ↗
  • MalfunctionSep 30, 2026Low Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into the arm on (b)(6) 2026. Data was evaluated and the allegation was undetermined. The allegation and the probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. The data investigation did not find blood glucose calibration values to compare to CGM values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported.

    Patient problems: Hyperglycemia

    MAUDE report 50950374 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over an hour was found in connection to the reported allegation. The probable cause of the signal loss was determined to be the transmitter and app were unable to complete a data transfer. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950248 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950154 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over an hour was found in connection to the reported allegation. The probable cause of the signal loss was determined to be the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949804 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that signal loss occurred. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour within the investigation window. The probable cause was the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949785 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that signal loss occurred. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour within the investigation window. The probable cause was the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949464 ↗
  • MalfunctionSep 30, 2026High Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into the arm on (b)(6) 2026. Data was evaluated and the allegation was undetermined. The probable cause could not be determined via data. The reported glucose values fall within the D zone of the Parkes Error Grid. The data investigation did not find blood glucose calibration values to compare to CGM values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported.

    Patient problems: Hypoglycemia

    MAUDE report 50949172 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949124 ↗
  • MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into the arm . It has been reported that there was a difference between Dexcom and BG readings was more than 20%. Data was evaluated and the allegation was undetermined. The probable cause could not be determined via data. There were no reported glucose values available to search within the Parkes Error Grid calculator. The data investigation did not find blood glucose calibration values to compare to CGM values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948836 ↗
  • MalfunctionSep 30, 2026Low Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into an off-label insertion site, on (b)(6)-2026. No data was provided for evaluation. The allegation and the probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.

    Patient problems: Hyperglycemia

    MAUDE report 50948832 ↗
  • MalfunctionSep 30, 2026Low Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into the arm on (b)(6) 2026. It has been reported that there was a difference in readings of more than 200 points. Data was evaluated and the allegation was confirmed. The probable cause could not be determined via data. The reported glucose values fall within the C zone of the Parkes Error Grid. The data investigation found a difference in values that fall within the B zone of the Parkes Error Grid. No injury or medical intervention was reported.

    Patient problems: Hyperglycemia

    MAUDE report 50948410 ↗

Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices

All Integrated Continuous Glucose Monitoring System, Factory Calibrated devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.