Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-013Recalls & reported problems
Dexcom, Inc. · G7 15 Day US Medicare Sensor 1pk · Class 2
Quick summary
This Dexcom G7 sensor is a continuous glucose monitor worn on the body to track blood sugar. The 1,507 reports most often describe wireless communication problems, low readings, the sensor detaching, and high readings. Some reports mention a foreign body in the patient. The reports list no deaths and 30 injuries. Reports in the last 12 months number 1,507, compared with 0 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
- 2,030
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,030 adverse event reports that list this exact device (DI 00386270004741), received between Dec 29, 2025 and Sep 30, 2026 — classified as 44 injuries, 1,984 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (1,411 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
Most reported problems
Device problems
- Wireless Communication Problem1,411
- Low Readings258
- Detachment of Device or Device Component158
- High Readings67
- Break39
- Premature End-of-Life Indicator28
- Incorrect, Inadequate or Imprecise Result or Readings23
- Inappropriate or Unexpected Reset11
Patient problems
- No Clinical Signs, Symptoms or Conditions1,646
- Hyperglycemia260
- Hypoglycemia67
- Foreign Body In Patient39
- Foreign Body Reaction15
- Rash12
- Loss of consciousness11
- Nausea11
Recent adverse event reports
The 25 most recent of 2,030 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 50954737 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954618 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954290 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952928 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952891 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952280 ↗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 50951959 ↗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 50951431 ↗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 50951104 ↗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 50950718 ↗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 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 falls within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50950366 ↗MalfunctionSep 30, 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 50949453 ↗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, on (b)(6) 2026. No data was provided for evaluation. 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 50949181 ↗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 50949111 ↗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 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 50948830 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that signal loss occurred OCCASIONALLY between 9/6/2026 and 9/14/2026. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour was found RARELY 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 50948809 ↗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 50948798 ↗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 50948794 ↗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 50948788 ↗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 complete a data transfer. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948414 ↗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 restore the connection. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946921 ↗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 50945804 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Product has been received but is pending evaluation. A follow up report will be submitted upon completion. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945802 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that warm-up takes longer than expected occurred. A review of the share logs was performed and the allegation was confirmed. The probable cause was determined to be signal loss. In addition, the probable cause of the signal loss could not be determined. The reported event of warm-up continued longer than intended duration is reportable based on the finding of signal loss greater than one hour. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944482 ↗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 50943819 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.