Dexcom G5 Mobile Android App SW10940Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,843 adverse event reports that list this exact device (DI 00386270000293), received between Jul 5, 2017 and Aug 11, 2020 — classified as 10 injuries, 3,833 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (3,481 reports).

2 other recalls cover devices cleared under the same FDA submission (P120005); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 3,843 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393473 ↗
• MalfunctionJun 25, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED NO READINGS ON THE MOBILE APP 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 POTENTIAL PATIENT MISUSE AS THE MOBILE DEVICE LOST POWER. THE REPORTED EVENT OF NO READINGS ON THE MOBILE APP IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS OVER ONE HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195533 ↗
• MalfunctionJun 23, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184726 ↗
• MalfunctionJun 19, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173991 ↗
• MalfunctionJun 16, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. DATA WAS EVALUATED AND CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160135 ↗
• MalfunctionJun 16, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. DATA WAS EVALUATED AND CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10159598 ↗
• MalfunctionJun 15, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153693 ↗
• MalfunctionJun 5, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. DATA WAS EVALUATED AND CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10126025 ↗
• MalfunctionApr 28, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT BLUETOOTH CONNECTION BETWEEN TRANSMITTER AND MOBILE APP ISSUE OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10006484 ↗
• MalfunctionApr 23, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991223 ↗
• MalfunctionApr 22, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE STARTING THE SENSOR SESSION. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE IS DETERMINED TO BE SENSOR EXPIRATION. THE REPORTED EVENT OF A SENSOR SESSION NOT STARTING IS REPORTABLE BASED ON THE FINDING OF A SENSOR EXPIRATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987885 ↗
• MalfunctionApr 20, 2020No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT NO AUDIO ON THE MOBILE APP OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE DEVICE FUNCTIONED WITHIN SPECIFICATIONS AND PATIENT SETTINGS. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978040 ↗
• MalfunctionApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A SENSOR STOPPED WORKING ON THE MOBILE APP OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT OF A SENSOR STOPPED WORKING IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS OVER ONE HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954899 ↗
• MalfunctionApr 9, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943520 ↗
• MalfunctionMar 30, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901679 ↗
• MalfunctionMar 24, 2020Alarm Not Visible; Alarm Not Visible

  IT WAS REPORTED THAT NO VISUAL ALERT ON THE MOBILE APP 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 NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874394 ↗
• MalfunctionMar 24, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9870749 ↗
• MalfunctionMar 23, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865206 ↗
• MalfunctionMar 19, 2020No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT NO AUDIO ON THE MOBILE APP 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 NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857194 ↗
• MalfunctionMar 19, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT AN APP ISSUE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A SIGNAL LOSS OVER AN HOUR. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT OF AN APP ISSUE IS REPORTABLE BASED ON THE FINDING OF A SIGNAL LOSS OVER AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857100 ↗
• MalfunctionMar 19, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856457 ↗
• MalfunctionMar 14, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9833051 ↗
• MalfunctionMar 12, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825832 ↗
• MalfunctionMar 12, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS DETERMINED THAT THE LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824380 ↗
• MalfunctionMar 6, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AN UNEXPECTED CGM APP SHUT-OFF 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 Consequences Or Impact To Patient

  MAUDE report 9803125 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120005. One submission often covers many models, so check the product and lot details in each record.

• Z-1561-2020 · Feb 3, 2020 · Terminated
  Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracki
• Z-1560-2020 · Feb 3, 2020 · Terminated
  Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends a