Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System 9510Recalls & reported problems

Dexcom, Inc. · G7 GSS 15-day Sensor · 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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386270004574), received between Sep 11, 2026 and Sep 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Sense” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Sense1
Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

Elevated Ketones/ Diabetic Ketoacidosis1

Recent adverse event reports

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

MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Sense
I am a 59-year-old woman with type 2 diabetes. I am not using insulin. I use a DexcomG7 15 Day CGM to monitor my glucose and use a blood glucose meter to verifyreadings when necessary. This is the sixth Dexcom G7 sensor I have experiencedsignificant problems with requiring replacement/reporting. Previous sensors haveproduced inaccurate readings, false low alerts, or sensor failures. The sensors were notall from the same lot. I have repeatedly contacted Dexcom regarding these problemsand have received replacement sensors. This sensor session began (b)(6) 2026. Duringthis sensor session, the Dexcom repeatedly produced readings that differedsubstantially from fingerstick measurements and displayed rapid changes that were notsupported by my blood glucose meter. Examples include Dexcom 337 mg/dL while mymeter was 255; Dexcom 185 while my meter was 104; Dexcom 290 while my meter was183; Dexcom 285 while my meter was 160; and Dexcom 203 while my meter was 114.On another occasion after eating dinner, the Dexcom rose to HIGH (>400 mg/dL) andgenerated an extreme-high warning. I did not have a simultaneous fingerstick at theexact peak, so I cannot determine my actual glucose at that moment. L
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50732872 ↗

Device details

UDI-DI	`00386270004574`
Brand	Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
Model	9510
Company	Dexcom, Inc.
Product code	QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Sep 17, 2025

Device type (GMDN): Percutaneous interstitial fluid glucose monitoring system, electrochemical

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices

Dexcom G6 Transmitter 9445-24
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
240,475 reports
Dexcom G6 Transmitter 9445-02
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
3 deaths229,493 reports
Dexcom G6 Sensor Applicator Assembly 9500-45
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
1 recall4 deaths114,678 reports
US G6 Transmitter (Retail, Receiver Optional) STT-OE-002
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
76,977 reports
Dexcom G7 GSS (161) 9500-161
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
70,146 reports
Dexcom G7 iOS App SW12300
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
3 recalls1 death55,219 reports
Dexcom G7 GSS (161) STP-AT-012
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
1 recall5 deaths48,180 reports
G6 Medicare Transmitter STT-OM-001
Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated
38,339 reports

All Integrated Continuous Glucose Monitoring System, Factory Calibrated devices →

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