Dexcom G6 iOS SW11677Recalls & reported problems
Dexcom, Inc. · G6 iOS · Class 2
All models of Dexcom G6 (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dexcom G6 iOS app has 23,505 adverse event reports in the FDA database, including 81 injuries and no deaths. Most reports describe wireless connection problems, the app shutting down on its own, and alarms that did not sound, and most state no impact on the patient. There is 1 closed recall, started in November 2019, because low alerts did not reliably notify users when the alert schedule was turned on after the app had been installed for some time.
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
- 23,526
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23,526 adverse event reports that list this exact device (DI 00386270000804), received between Feb 15, 2018 and Sep 30, 2026 — classified as 83 injuries, 23,443 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (15,812 reports).
1 FDA recall record name this device's identifier.
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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 19, 2019Terminated
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
Z-1104-2020 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Wireless Communication Problem15,812
- Unintended Application Program Shut Down5,210
- Appropriate Device Problem Term/Code Not Available948
- No Audible Alarm546
- Defective Alarm291
- Operating System Version or Upgrade Problem177
- Alarm Not Visible159
- Application Program Freezes or Fails to Launch135
Patient problems
- No Consequences Or Impact To Patient18,700
- No Clinical Signs, Symptoms or Conditions4,741
- Hypoglycemia55
- Loss of consciousness41
- No Known Impact Or Consequence To Patient9
- Convulsion/Seizure7
- Elevated Ketones/ Diabetic Ketoacidosis7
- Hyperglycemia6
Recent adverse event reports
The 25 most recent of 23,526 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50949807 ↗MalfunctionSep 28, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926155 ↗MalfunctionSep 28, 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 50923370 ↗MalfunctionSep 26, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906373 ↗MalfunctionSep 24, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. Data was evaluated and the allegation was confirmed. The probable cause was determined to be the mobile device updated OPERATING SYSTEM which closed the app. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877952 ↗MalfunctionSep 23, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876143 ↗MalfunctionSep 23, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876043 ↗MalfunctionSep 23, 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 50870428 ↗MalfunctionSep 22, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. 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 50850112 ↗MalfunctionSep 22, 2026Unintended Application Program Shut Down
It was reported that"Dexcom Application Crash" occurred. No product or data was provided for investigation. The allegation and the probable cause cannot be determined.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849969 ↗MalfunctionSep 21, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847183 ↗MalfunctionSep 18, 2026Operating System Version or Upgrade Problem
It was reported that CGM app and OS incompatible due to unsupported OS on Smart Device occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. No data or product was provided for investigation. The allegation was undetermined. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823021 ↗MalfunctionSep 17, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. 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 50809053 ↗MalfunctionSep 17, 2026Wireless Communication Problem
It was reported that a Dexcom App Crash occurred. Performance data was reviewed. The allegation was confirmed. The probable cause was determined to be an SQL error. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809021 ↗MalfunctionSep 17, 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 50804490 ↗MalfunctionSep 15, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781796 ↗MalfunctionSep 15, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781768 ↗MalfunctionSep 14, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764363 ↗MalfunctionSep 11, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743094 ↗InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available
It was reported that an alert/notification settings issue occurred. The sensor was inserted into the skin. On (b)(6) 2026, it was reported that the patient reported having unspecified high CGM values. She reported she received no alerts from her Dexcom mobile app notifying her of her hyperglycemic state but only found out her CGM value was elevated by manually checking her device. The patient was also wearing a Tandem insulin pump. The patient began to feel nauseous, unwell, and had ketones. Emergency medical services (EMS) was called and the patient was taken to the Emergency room (ER). At the ER, the patient was treated with insulin, an anti-nausea medication, and IV saline. The patient was discharged after approximately nine hours. The patient was ¿fine¿ at the time of report. Data has been received but is pending evaluation. A follow up report will be submitted upon completion. No additional patient or event information is available.
Patient problems: Hyperglycemia; Malaise; Nausea
MAUDE report 50736715 ↗MalfunctionSep 9, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693608 ↗MalfunctionAug 31, 2026No Audible Alarm
Subsequent to the initial MDR, it was determined that a report was submitted in error. Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50526899 ↗MalfunctionAug 28, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508203 ↗MalfunctionAug 28, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504805 ↗MalfunctionAug 28, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504786 ↗
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- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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