Dexcom G6 Android SW11678Recalls & reported problems
Dexcom, Inc. · G6 Android · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Dexcom G6 Android app has 4,044 adverse event reports, including 1 death, 35 injuries and 4,008 malfunctions. The reports mostly describe the app shutting down unexpectedly, wireless connection problems and alarms that do not sound. 1 open recall, from August 2025, concerns a software problem that can close the app, so glucose readings and alerts may not arrive.
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
- 4,055
- Deaths reported
- 1
- Injuries reported
- 34
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,055 adverse event reports that list this exact device (DI 00386270000811), received between May 31, 2018 and Sep 25, 2026 — classified as 1 death, 34 injuries, 4,020 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (2,401 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 28, 2025Open, Classified
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
Z-0318-2026 · Root cause: Software Design Change · FDA record ↗
Most reported problems
Device problems
- Wireless Communication Problem2,401
- Unintended Application Program Shut Down991
- Operating System Version or Upgrade Problem155
- No Audible Alarm135
- Appropriate Device Problem Term/Code Not Available110
- Defective Alarm83
- Application Program Freezes or Fails to Launch59
- Alarm Not Visible36
Patient problems
- No Consequences Or Impact To Patient2,557
- No Clinical Signs, Symptoms or Conditions1,463
- Hypoglycemia21
- Elevated Ketones/ Diabetic Ketoacidosis10
- Loss of consciousness7
- Confusion/ Disorientation6
- Vomiting5
- Dizziness4
Recent adverse event reports
The 25 most recent of 4,055 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Unintended Application Program Shut Down
It was reported that an alert/notification setting occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that an app crash occurred 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 50898941 ↗MalfunctionSep 24, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891111 ↗MalfunctionSep 24, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877955 ↗MalfunctionSep 22, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Performance data was reviewed. The allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850281 ↗MalfunctionSep 21, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848913 ↗MalfunctionSep 21, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847190 ↗MalfunctionSep 17, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810426 ↗MalfunctionSep 17, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Performance data was reviewed. The allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810166 ↗MalfunctionSep 9, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696697 ↗MalfunctionSep 8, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673876 ↗MalfunctionSep 8, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Performance data was reviewed. The allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670980 ↗MalfunctionSep 2, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569877 ↗MalfunctionAug 31, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531843 ↗MalfunctionAug 31, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531210 ↗MalfunctionAug 28, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504841 ↗MalfunctionAug 19, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50312309 ↗MalfunctionAug 18, 2026Wireless Communication Problem
It was reported that no readings occurred. Data was provided for investigation. Confirmation of the complaint was confirmed via data. However, signal loss over an hour was found in connection to the allegation. 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 50290816 ↗MalfunctionAug 17, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Performance data was reviewed. The allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288884 ↗MalfunctionAug 14, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50259312 ↗MalfunctionAug 14, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257207 ↗MalfunctionAug 12, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223239 ↗MalfunctionAug 11, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204100 ↗MalfunctionAug 11, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203882 ↗MalfunctionAug 7, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180530 ↗MalfunctionAug 3, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122295 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
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- 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.