Dexcom Follow App for Android SW10583Recalls & reported problems
Dexcom, Inc. · US Dexcom Follow App for Android (mg/dL), v4 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00386270001917), received between Jul 13, 2025 and Nov 10, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Defective Alarm” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Alarm2
- Display or Visual Feedback Problem2
- No Audible Alarm2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Display or Visual Feedback Problem; Display 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 23512517 ↗MalfunctionOct 17, 2025Defective Alarm; Defective Alarm
IT WAS REPORTED THAT "ALERT/NOTIFICATION SETTINGS" 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 23330911 ↗MalfunctionAug 23, 2025No Audible Alarm; No 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 22881289 ↗MalfunctionAug 23, 2025No Audible Alarm; No 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 22881025 ↗MalfunctionJul 28, 2025Defective Alarm; Defective 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 22637654 ↗MalfunctionJul 13, 2025Display or Visual Feedback Problem; Display 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 22490561 ↗
Other Continuous Glucose Monitor Secondary Display devices
- t:connect Mobile Application (iOS) 1004128Tandem Diabetes Care, Inc. · Continuous Glucose Monitor Secondary Display1 recall0 reports
- Dexcom Follow App for iOS SW10497Dexcom, Inc. · Continuous Glucose Monitor Secondary Display35 reports
- Dexcom Follow 5 Android Mobile SW14256Dexcom, Inc. · Continuous Glucose Monitor Secondary Display7 reports
- LibreLinkUp 72154-01Abbott Diabetes Care Inc · Continuous glucose monitor secondary display4 reports
- t:connect Mobile Application, Mobile Bolus Enabled (iOS) 1007111Tandem Diabetes Care, Inc. · Continuous Glucose Monitor Secondary Display3 reports
- Dexcom Follow 5 iOS Mobile SW14255Dexcom, Inc. · Continuous Glucose Monitor Secondary Display2 reports
- t:connect Mobile Application (Android) 1004127Tandem Diabetes Care, Inc. · Continuous Glucose Monitor Secondary Display1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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