Dexcom G5 Mobile Receiver Kit STK-GF-BLURecalls & reported problems
Dexcom, Inc. · G5 Mobile Receiver Kit Adult Blue · Class 3
All models of Dexcom G5 (21) · Dexcom G5 Mobile Receiver Kit (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dexcom G5 mobile receiver kit is a receiver that shows glucose readings and alerts from a Dexcom sensor. Its 2,845 reports mostly describe wrong messages on the screen, unexpected shutdowns or resets, lost wireless signal, and alarms that do not work properly. The reports include 1 death and 9 injuries, though most say no patient impact was reported. There is 1 closed recall, started in July 2019, over software that could leave the receiver stuck on its startup screen.
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
- 2,845
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,845 adverse event reports that list this exact device (DI 30386270000270), received between Aug 17, 2016 and May 18, 2020 — classified as 1 death, 9 injuries, 2,835 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1,513 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Displays Incorrect Message1,513
- Inappropriate or Unexpected Reset432
- Wireless Communication Problem211
- Defective Alarm206
- Unable to Obtain Readings150
- Device Inoperable145
- No Audible Alarm74
- Unexpected Shutdown31
Patient problems
- No Consequences Or Impact To Patient2,836
- Hypoglycemia7
- Elevated Ketones/ Diabetic Ketoacidosis2
- Death1
- Fainting1
- Fall1
- Injury1
- Loss of consciousness1
Recent adverse event reports
The 25 most recent of 2,845 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 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 10066598 ↗MalfunctionApr 8, 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 9937984 ↗MalfunctionJan 27, 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 9631443 ↗MalfunctionJan 8, 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 9563585 ↗MalfunctionJan 8, 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 9563576 ↗MalfunctionJan 6, 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 9552515 ↗MalfunctionDec 11, 2019Wireless 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 Consequences Or Impact To Patient
MAUDE report 9452615 ↗MalfunctionDec 10, 2019Unexpected 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 9443557 ↗MalfunctionDec 3, 2019Unexpected 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 9402476 ↗MalfunctionNov 23, 2019Wireless 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. A CHARGE AND BOOT TEST WAS PERFORMED AND PASSED. A PAIRING TEST WAS PERFORMED AND PASSED. A RECEIVER FUNCTIONAL TEST WAS PERFORMED AND PASSED. THERE WAS NO DATA WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS UNDETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9366882 ↗MalfunctionNov 18, 2019Wireless 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 Consequences Or Impact To Patient
MAUDE report 9336244 ↗MalfunctionNov 16, 2019Wireless 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 Consequences Or Impact To Patient
MAUDE report 9333340 ↗MalfunctionNov 14, 2019Unable 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 9321072 ↗MalfunctionNov 8, 2019Unable 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 9298874 ↗MalfunctionNov 7, 2019Unable 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 9292534 ↗MalfunctionOct 31, 2019Wireless 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 Consequences Or Impact To Patient
MAUDE report 9262337 ↗MalfunctionOct 25, 2019Unable 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 9240081 ↗MalfunctionOct 7, 2019Unexpected 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 9161805 ↗MalfunctionOct 2, 2019Unable 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 9145967 ↗MalfunctionOct 2, 2019Unable 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 9145491 ↗MalfunctionSep 30, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART 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 9136734 ↗MalfunctionSep 26, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. 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 9124535 ↗MalfunctionSep 20, 2019Unable 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 9100863 ↗MalfunctionSep 19, 2019Unable 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 9088078 ↗MalfunctionSep 19, 2019Unable 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 9087712 ↗
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 · TerminatedDexcom 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 · TerminatedDexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracki
Other Sensor, Glucose, Invasive devices
- Dexcom G4 Platinum Sensor 9500-27Dexcom, Inc. · Sensor, Glucose, Invasive2 recalls2 deaths99,426 reports
- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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