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
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 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
- Dexcom G6 Transmitter 9445-24Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated240,475 reports
- Dexcom G6 Transmitter 9445-02Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 deaths229,493 reports
- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated76,977 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page