Dexcom G5Recalls & reported problems across all models

We found 21 models of Dexcom G5 by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 206,314 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2015 and Oct 10, 2024 — classified as 4 deaths, 467 injuries, 205,843 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (104,024 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Dexcom G5 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 12, 2019Terminated

   It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.

   Z-0929-2020 · Root cause: Software design · names 10 of these models · Recall details · FDA record ↗

Most reported Dexcom G5 problems

Dexcom G5 models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dexcom G5 Transmitter Kit STT-GF-001

  Sensor, Glucose, Invasive
  1 death58,932 reports
• Dexcom G5 Mobile IOS App SW10611

  Sensor, Glucose, Invasive
  54,544 reports
• Dexcom G5 Mobile Transmitter Kit (Medicare) STT-MC-001

  Sensor, Glucose, Invasive, Non-Adjunctive
  18,422 reports
• Dexcom G5 Transmitter 9438-06

  Sensor, Glucose, Invasive
  15,360 reports
• Dexcom G5 Mobile Receiver MT22719

  Sensor, Glucose, Invasive
  1 death12,594 reports
• Dexcom G5 Mobile Receiver MT22719-BLU

  Sensor, Glucose, Invasive
  7,685 reports
• Dexcom G5 Mobile Receiver Kit STK-GF-001

  Sensor, Glucose, Invasive
  1 recall6,345 reports
• Dexcom G5 Mobile Receiver MT22719-PNK

  Sensor, Glucose, Invasive
  1 death6,048 reports
• Dexcom G5 Mobile Replacement Receiver Kit STR-GF-001

  Sensor, Glucose, Invasive
  1 recall4,836 reports
• Dexcom G5 Mobile Replacement Receiver Kit (Medicare) STR-MC-001

  Sensor, Glucose, Invasive, Non-Adjunctive
  4,734 reports
• Dexcom G5 Transmitter Kit (Retail) STT-RF-001

  Sensor, Glucose, Invasive
  4,172 reports
• Dexcom G5 Mobile Android App SW10940

  Sensor, Glucose, Invasive, Non-Adjunctive
  3,843 reports
• Dexcom G5 Mobile Receiver Kit STK-GF-BLU

  Sensor, Glucose, Invasive
  1 recall1 death2,845 reports
• Dexcom G5 Mobile Replacement Receiver Kit STR-GF-BLU

  Sensor, Glucose, Invasive
  1 recall1,822 reports
• Dexcom G5 Mobile Replacement Receiver Kit STR-GF-PNK

  Sensor, Glucose, Invasive
  1 recall1,480 reports
• Dexcom G5 Mobile Receiver Kit (Retail) STK-RF-001

  Sensor, Glucose, Invasive
  1 recall980 reports
• Dexcom G5 Mobile Receiver Kit (Medicare) STK-MC-001

  Sensor, Glucose, Invasive, Non-Adjunctive
  1 recall494 reports
• Dexcom G5 Mobile Receiver Kit STK-GF-PNK

  Sensor, Glucose, Invasive
  1 recall485 reports
• Dexcom G5 Mobile Receiver Kit (Retail) STK-RF-BLU

  Sensor, Glucose, Invasive
  1 recall368 reports
• Dexcom G5 Mobile Receiver Kit (Retail) STK-RF-PNK

  Sensor, Glucose, Invasive
  1 recall311 reports
• Dexcom G5 Touchscreen Receiver STK-SR-001

  Sensor, Glucose, Invasive, Non-Adjunctive
  14 reports

Recent Dexcom G5 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAY 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 20424861 ↗
• MalfunctionMay 21, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT A TRANSMITTER BATTERY 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 19360480 ↗
• MalfunctionMar 23, 2024Unable to Obtain Readings; Unable to Obtain Readings

  SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965984 ↗
• MalfunctionOct 24, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE TEST WAS PERFORMED AND PASSED. RECEIVER BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TEST WAS PERFORMED AND PASSED. A TOUCHSCREEN MANUAL BUTTON TEST WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT 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 17998689 ↗
• MalfunctionOct 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. 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 17885622 ↗
• MalfunctionAug 22, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. 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 17597766 ↗
• MalfunctionJul 19, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED 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 17356408 ↗
• MalfunctionJul 11, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED 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 17300472 ↗
• MalfunctionJun 2, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PRODUCT WAS EVALUATED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. A RECEIVER TOUCH SCREEN MANUAL TEST WAS PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT 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 17050122 ↗
• MalfunctionMay 11, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED 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 16914288 ↗
• MalfunctionJan 26, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, WHICH IS OFF-LABEL USAGE OF THE DEVICE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247002 ↗
• MalfunctionJan 5, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16106066 ↗
• MalfunctionJan 5, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED 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 16102132 ↗
• MalfunctionDec 30, 2022No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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 16080857 ↗
• MalfunctionDec 19, 2022No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011196 ↗

Other Dexcom, Inc. products

• Dexcom G613 models · 637,302 reports · 7 recalls
• Dexcom G6 Transmitter2 models · 469,968 reports
• Dexcom G732 models · 325,909 reports · 8 recalls
• Dexcom G7 GSS (161)4 models · 141,244 reports · 1 recall
• Dexcom G4 Platinum41 models · 119,308 reports · 2 recalls
• Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
• Dexcom G7 GSS (160)4 models · 33,558 reports
• Dexcom G5 Mobile Receiver3 models · 26,327 reports