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Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STE-FT-016Recalls & reported problems

Dexcom, Inc. · G7 15 Day US Sample Pack · Class 2

All models of Dexcom G7 (32) · Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Dexcom G7 glucose monitor is a sensor worn on the body to track glucose levels. Its 740 reports mostly describe wireless communication problems such as signal loss, along with low or high readings and sensors that detached. The reports include no deaths and 23 injuries, and all 740 came in the latest 12 months, compared with none in the 12 months before. 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
912
Deaths reported
0
Injuries reported
33
Recalls naming it
0

Summary

The FDA's MAUDE database contains 912 adverse event reports that list this exact device (DI 00386270004727), received between Jan 7, 2026 and Sep 30, 2026 — classified as 33 injuries, 878 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (720 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.

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: 6 reportsFeb 2026: 22 reportsMar 2026: 59 reportsApr 2026: 84 reportsMay 2026: 132 reportsJun 2026: 143 reportsJul 2026: 159 reportsAug 2026: 129 reportsSep 2026: 178 reportsOct 2026: 0 reports202420252026178
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Wireless Communication Problem720
  • Low Readings107
  • High Readings27
  • Detachment of Device or Device Component21
  • Appropriate Device Problem Term/Code Not Available11
  • Incorrect, Inadequate or Imprecise Result or Readings6
  • Break5
  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions760
  • Hyperglycemia107
  • Hypoglycemia29
  • Loss of consciousness9
  • Foreign Body In Patient8
  • Confusion/ Disorientation7
  • Diaphoresis6
  • Dizziness6

Recent adverse event reports

The 25 most recent of 912 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 50954846 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50952029 ↗
  • 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 50950678 ↗
  • 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 could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950176 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that a pairing issue occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. 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 50949482 ↗
  • InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

    Patient problems: Blurred Vision; Headache; Hypoglycemia; Malaise; Nausea; Presyncope

    MAUDE report 50949477 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949146 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948777 ↗
  • 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 50948050 ↗
  • 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 50947380 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    It was reported that physical damage occurred. The sensor was inserted into the Arm on (b)(6) 2026. Product was provided for investigation. An external visual inspection was performed and failed due to a Missing needle. Physical damage was not found within the investigation window. The allegation was not confirmed. However, a broken or detached needle or cannula was found in connection to the reported event. The probable cause of the broken or detached needle or cannula could not be determined. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946919 ↗
  • 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 50946631 ↗
  • MalfunctionSep 30, 2026Wireless Communication Problem

    It was reported that signal loss occurred FREQUENTLY between (b)(6) 2026. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour was found OCCASIONALLY 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 50946427 ↗
  • InjurySep 30, 2026High Readings

    It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The wearable was inserted into the arm on (b)(6) 2026. On 09/15/2026, the patient was lying down and browsing on her phone when she suddenly experienced cold sweats, dizziness, and blurred vision. She checked her Dexcom CGM, which displayed a glucose reading of 80 mg/dL. Due to her symptoms, she performed a blood glucose meter (BGM) check, which showed a reading of 59 mg/dL. The patient self-treated with apple juice. Approximately 10 to 15 minutes later, she rechecked her glucose levels. Her BGM reading was 62 mg/dL, while her Dexcom reading was 84 mg/dL. Despite treatment, she continued to experience cold sweats and dizziness, prompting her to call 911. When paramedics arrived, they performed a glucose check. The BGM reading was 61 mg/dL, while her Dexcom displayed 85 mg/dL. Due to her persistent symptoms and low blood glucose levels, paramedics administered a glucose injection (glucagon) and transported her to the hospital for further evaluation. Upon arrival at the hospital, the attending physician checked her blood glucose, which measured 60 mg/dL. Her Dexc

    Patient problems: Blurred Vision; Diaphoresis; Dizziness; Hypoglycemia

    MAUDE report 50945577 ↗
  • 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 50942323 ↗
  • 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 50941752 ↗
  • MalfunctionSep 29, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940977 ↗
  • MalfunctionSep 29, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50938764 ↗
  • MalfunctionSep 29, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50937824 ↗
  • 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 restore the connection. No injury or medical intervention was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50935853 ↗
  • MalfunctionSep 29, 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 50935258 ↗
  • InjurySep 29, 2026High Readings

    Patient problems: Chills; Diaphoresis; Fatigue; Hypoglycemia; Loss of consciousness

    MAUDE report 50934948 ↗
  • MalfunctionSep 29, 2026Wireless Communication Problem

    It was reported that a signal loss occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. 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 50934582 ↗
  • MalfunctionSep 29, 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 50934294 ↗
  • MalfunctionSep 29, 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 50933934 ↗

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Sources and updates

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