Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 627 adverse event reports that list this exact device (DI 00386270004758), received between Jan 5, 2026 and Sep 30, 2026 — classified as 14 injuries, 613 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (427 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 627 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Readings

  Patient problems: Hypoglycemia

  MAUDE report 50954772 ↗
• MalfunctionSep 30, 2026High Readings

  Patient problems: Hypoglycemia

  MAUDE report 50954318 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949144 ↗
• 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 50948806 ↗
• 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 50948784 ↗
• 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 50947680 ↗
• 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 50946413 ↗
• 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 50943800 ↗
• 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 50942387 ↗
• 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 50942327 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred FREQUENTLY between 9/10/2026 and 9/11/2026. The sensor was inserted into the arm on (b)(6) 2026. It was indicated that the patient entered BG values outside the 40¿400 mg/dL (2.2¿22.2 mmol/L) range, which is misuse of the device. Data was provided for investigation. The allegation was confirmed due to the finding of inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred FREQUENTLY within the investigation window. The probable cause of the inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter could not be determined. 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 D zone of the Parkes Error Grid. No injury or medical intervention was reported.

  Patient problems: Hyperglycemia

  MAUDE report 50941913 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Nodule; Pain; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 50941001 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939010 ↗
• MalfunctionSep 29, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938946 ↗
• MalfunctionSep 29, 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 was indicated that the patient entered BG values outside the 40¿400 mg/dL (2.2¿22.2 mmol/L) range, which is misuse of the device. No data was provided for evaluation. Confirmation of the allegation and a 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 50934350 ↗
• MalfunctionSep 29, 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 complete a data transfer. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931898 ↗
• MalfunctionSep 28, 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 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: Hyperglycemia

  MAUDE report 50923154 ↗
• MalfunctionSep 28, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923123 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920967 ↗
• MalfunctionSep 28, 2026Wireless Communication Problem

  It was reported that"Signal Loss" occurred. No product or data was provided for investigation. The allegation and the probable cause cannot be determined. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917102 ↗
• MalfunctionSep 28, 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 50916507 ↗
• MalfunctionSep 28, 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 confirmed. 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 found a difference in values that fall within the D of the Parkes Error Grid. No injury or medical intervention was reported.

  Patient problems: Hyperglycemia

  MAUDE report 50914768 ↗
• MalfunctionSep 25, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903980 ↗
• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903550 ↗
• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902539 ↗