Dexcom G5 Transmitter Kit (Retail) STT-RF-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,172 adverse event reports that list this exact device (DI 20386270000228), received between Jan 26, 2017 and May 12, 2021 — classified as 4,172 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (1,944 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 4,172 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021No Device Output; No Device Output

  IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11813947 ↗
• MalfunctionMar 29, 2021No Device Output; No Device Output

  IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VOLTS. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11581933 ↗
• MalfunctionMar 19, 2021No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VOLTS. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529839 ↗
• MalfunctionFeb 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TRANSMITTER STOPPED WORKING OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A VOLTAGE TEST WAS PERFORMED AND FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A TRANSMITTER FAILED ERROR. THE REPORTED EVENT OF THE TRANSMITTER STOPPED WORKING IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298594 ↗
• MalfunctionJan 28, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248001 ↗
• MalfunctionJan 26, 2021No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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 11232393 ↗
• MalfunctionJan 25, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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 11228217 ↗
• MalfunctionJan 14, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL/EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE CHECK WAS PERFORMED AND PASSED. PAIRING TEST/DOWNLOAD WAS PERFORMED AND PASSED. A REVIEW OF THE BIN FILE WAS PERFORMED AND SIGNAL LOSS 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11171039 ↗
• MalfunctionJan 7, 2021No 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 11131593 ↗
• MalfunctionDec 28, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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 11084968 ↗
• MalfunctionDec 23, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11066925 ↗
• MalfunctionDec 22, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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 11055723 ↗
• MalfunctionDec 21, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11052970 ↗
• MalfunctionDec 15, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0V. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11006124 ↗
• MalfunctionDec 9, 2020No 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 Consequences Or Impact To Patient

  MAUDE report 10979948 ↗
• MalfunctionDec 3, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED . TRANSMITTER VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. 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 Consequences Or Impact To Patient

  MAUDE report 10942481 ↗
• MalfunctionDec 2, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0V. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10931375 ↗
• MalfunctionDec 1, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. 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 Consequences Or Impact To Patient

  MAUDE report 10930897 ↗
• MalfunctionDec 1, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. 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 Consequences Or Impact To Patient

  MAUDE report 10927704 ↗
• MalfunctionDec 1, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 10924708 ↗
• MalfunctionNov 27, 2020No 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 Consequences Or Impact To Patient

  MAUDE report 10913959 ↗
• MalfunctionNov 26, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VOLTAGE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. 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 Consequences Or Impact To Patient

  MAUDE report 10909349 ↗
• MalfunctionNov 24, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. 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 Consequences Or Impact To Patient

  MAUDE report 10891229 ↗
• MalfunctionNov 23, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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 10886744 ↗
• MalfunctionNov 19, 2020No 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 Consequences Or Impact To Patient

  MAUDE report 10868301 ↗

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-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
• 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