Dexcom G5 Mobile Receiver KitRecalls & reported problems across all models

We found 3 models of Dexcom G5 Mobile Receiver Kit by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 9,675 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2016 and Oct 10, 2024 — classified as 1 death, 40 injuries, 9,634 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5,053 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 Mobile Receiver Kit 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, 2019Class IITerminated

   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 3 of these models · Recall details · FDA record ↗

Most reported Dexcom G5 Mobile Receiver Kit problems

Dexcom G5 Mobile Receiver Kit models

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

• Dexcom G5 Mobile Receiver Kit STK-GF-001

  Sensor, Glucose, Invasive
  1 recall6,345 reports
• Dexcom G5 Mobile Receiver Kit STK-GF-BLU

  Sensor, Glucose, Invasive
  1 recall1 death2,845 reports
• Dexcom G5 Mobile Receiver Kit STK-GF-PNK

  Sensor, Glucose, Invasive
  1 recall485 reports

Recent Dexcom G5 Mobile Receiver Kit 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 ↗
• MalfunctionMar 18, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11515326 ↗
• MalfunctionOct 21, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10711975 ↗
• MalfunctionOct 5, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10627545 ↗
• MalfunctionOct 5, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT UNEXPECTED RECEIVER SHUTDOWN OCCURRED. NO PRODUCT OR DATA 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 10626592 ↗
• MalfunctionAug 17, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10413790 ↗
• MalfunctionAug 6, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT A UNEXPECTED RECEIVER SHUT-DOWN OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376816 ↗
• MalfunctionJul 30, 2020Unable to Obtain Readings; Unable to Obtain Readings

  THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING ERROR RELATED TO THE COMPLAINT. 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 10347351 ↗
• MalfunctionJul 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND FAILED DUE TO THE RECEIVER NOT POWERING ON. FUNCTIONAL TESTS WERE NOT PERFORMED DUE TO THE RECEIVER NOT POWERING ON. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS NOT DOWNLOADED AND REVIEWED DUE TO THE RECEIVER NOT TURNING ON. THE ALLEGATION WAS UNDETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED AS THE ALLEGATION WAS NOT FOUND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10345297 ↗
• MalfunctionJul 28, 2020Display 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. 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 10332052 ↗
• MalfunctionJul 24, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10319537 ↗
• MalfunctionJul 22, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10308653 ↗
• MalfunctionJul 22, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA 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 10307227 ↗

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 G521 models · 206,314 reports · 1 recall
• 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