Dexcom G7 iOS App SW12300Recalls & reported problems

Summary

The FDA's MAUDE database contains 55,219 adverse event reports that list this exact device (DI 00386270001863), received between Dec 30, 2022 and Sep 30, 2026 — classified as 1 death, 172 injuries, 55,042 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (39,306 reports).

3 FDA recall records name this device's identifier, 3 still open.

3 other recalls cover devices cleared under the same FDA submission (K213919); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 14, 2026Open, Classified

   A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

   Z-2163-2026 · Root cause: Software design · FDA record ↗

2. Jul 24, 2025Open, Classified

   The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.

   Z-2447-2025 · Root cause: Software design · FDA record ↗

3. May 5, 2025Open, Classified

   A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.

   Z-1906-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55,219 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954759 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954639 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954623 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  It was reported that an alert/notification settings 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 50951161 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  It was reported that an alert/notification settings 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 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 50951152 ↗
• MalfunctionSep 30, 2026No Audible Alarm

  It was reported that an alert/notification settings issue 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 50951151 ↗
• 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. It was determined that the signal loss was related to the mobile application. 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 50949821 ↗
• MalfunctionSep 30, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949789 ↗
• MalfunctionSep 30, 2026No Audible Alarm

  It was reported that an alert/notification settings issue 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 50948470 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  It was reported that signal loss occurred. It was determined that loss of connection was related to the Mobile Application. 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 50948398 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  It was reported that an alert/notification settings 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 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 50948142 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that a display issue occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. Data was provided for investigation. Confirmation of the complaint was confirmed via data. The probable cause could not be determined. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947714 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that a display issue occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. Data was provided for investigation. Confirmation of the complaint was confirmed via data. The probable cause could not be determined. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947648 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that an alert/notification settings 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 undetermined via data. However, it was found that EGVs not updating issue 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 50947339 ↗
• MalfunctionSep 30, 2026Unintended Application Program Shut Down

  It was reported that an alert/notification settings 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 50947321 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  It was reported that an alert/notification settings issue occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. Performance data was reviewed. An alert issue was not found within the investigation window. The allegation was undetermined. However, signal loss over 1 hour was found in in connection to the reported allegation. The probable cause of the signal loss 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 50947319 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that EGVs not updating issue 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 50947309 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  It was reported that signal loss occurred. It was determined that loss of connection was related to the Mobile Application. A review of the share logs was performed and signal loss was found within the investigation window. The allegation was confirmed. The probable cause was 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 50943810 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that a display issue occurred. Data was provided for investigation. Confirmation of the complaint was confirmed via data. The probable cause could not be determined. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943322 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941491 ↗
• MalfunctionSep 29, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940302 ↗
• MalfunctionSep 29, 2026Operating System Version or Upgrade Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939760 ↗
• MalfunctionSep 29, 2026Operating System Version or Upgrade Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939734 ↗
• MalfunctionSep 29, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938510 ↗
• MalfunctionSep 29, 2026Display or Visual Feedback Problem

  It was reported that an alert/notification settings 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 undetermined via data. However, it was found that EGVs not updating issue 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 50938473 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213919. One submission often covers many models, so check the product and lot details in each record.

• Z-2448-2025 · Jul 24, 2025 · Open, Classified
  Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Produc
• Z-2446-2025 · Jul 24, 2025 · Open, Classified
  Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product
• Z-1944-2025 · May 12, 2025 · Open, Classified
  Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013