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Dexcom G5 Transmitter Kit STT-GF-001Recalls & reported problems

Dexcom, Inc. · G5 Transmitter Kit · Class 3

Quick summary

This is a Dexcom G5 transmitter kit. Its reports mostly describe transmitter failure errors, some traced to a low battery, along with lost wireless signal and no device output. There are 58,932 reports, including 1 death and 60 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
58,932
Deaths reported
1
Injuries reported
60
Recalls naming it
0

Summary

The FDA's MAUDE database contains 58,932 adverse event reports that list this exact device (DI 10386270000221), received between Jan 21, 2016 and Jan 26, 2023 — classified as 1 death, 60 injuries, 58,871 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (26,789 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

Device problems

  • Wireless Communication Problem26,789
  • Device Displays Incorrect Message17,049
  • No Device Output7,828
  • Premature End-of-Life Indicator2,171
  • Low Battery1,592
  • Communication or Transmission Problem1,428
  • Device Operates Differently Than Expected681
  • Imprecision449

Patient problems

  • No Consequences Or Impact To Patient53,012
  • No Known Impact Or Consequence To Patient5,280
  • No Clinical Signs, Symptoms or Conditions607
  • Hypoglycemia27
  • Loss of consciousness16
  • Seizures7
  • Hyperglycemia6
  • Malaise6

Recent adverse event reports

The 25 most recent of 58,932 reports, in the reporter's own words as published by the FDA.

  • 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 ↗
  • 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 14, 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 15980170 ↗
  • MalfunctionOct 26, 2022Wireless Communication Problem; Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 Clinical Signs, Symptoms or Conditions

    MAUDE report 15677602 ↗
  • MalfunctionSep 16, 2022Connection Problem; Connection Problem

    IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS. IN ADDITION, THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF THE SIGNAL LOSS OVER ONE HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15437916 ↗
  • MalfunctionAug 26, 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 15307439 ↗
  • MalfunctionAug 18, 2022Connection Problem; Connection Problem

    IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. THE REPORTED EVENT OF A PAIRING FAILURE 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 15254438 ↗
  • MalfunctionApr 14, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14112840 ↗
  • MalfunctionMar 17, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13802413 ↗
  • MalfunctionMar 11, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13731354 ↗
  • MalfunctionMar 10, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13723623 ↗
  • MalfunctionMar 1, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13633007 ↗
  • MalfunctionFeb 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13536584 ↗
  • MalfunctionFeb 11, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13515063 ↗
  • MalfunctionFeb 2, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13423931 ↗
  • MalfunctionJan 12, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13236165 ↗
  • MalfunctionJan 10, 2022Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13205952 ↗
  • MalfunctionDec 22, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13064192 ↗
  • MalfunctionDec 13, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12986595 ↗
  • MalfunctionNov 23, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12862786 ↗
  • MalfunctionNov 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12780769 ↗
  • MalfunctionSep 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12448747 ↗
  • MalfunctionSep 8, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12439816 ↗
  • MalfunctionAug 27, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12378404 ↗

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

Other Sensor, Glucose, Invasive devices

All Sensor, Glucose, Invasive devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.