Dexcom Receiver Kit (Medicare) STK-MD-001Recalls & reported problems
Dexcom, Inc. · Dexcom Receiver Kit (Medicare) · Class 3
Quick summary
This Dexcom Receiver Kit shows glucose readings from a Dexcom sensor. Many of its 963 reports describe wireless connection problems, failure to get readings and unexpected shutdowns, and most note no impact on the patient. The reports mention no deaths and 5 injuries. No recalls name this device, and only 4 reports came in the last 12 months compared with 15 in the previous 12 months.
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
- 963
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 963 adverse event reports that list this exact device (DI 00386270000859), received between May 14, 2019 and Apr 22, 2026 — classified as 5 injuries, 958 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (285 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.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem285
- Unable to Obtain Readings213
- Unexpected Shutdown189
- Defective Alarm81
- Display or Visual Feedback Problem71
- Inappropriate or Unexpected Reset59
- No Audible Alarm40
- Low Audible Alarm11
Patient problems
- No Consequences Or Impact To Patient587
- No Clinical Signs, Symptoms or Conditions386
- Hypoglycemia3
- Loss of consciousness3
- Coma1
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hypothermia1
- Nausea1
Recent adverse event reports
The 25 most recent of 963 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 24956046 ↗MalfunctionDec 1, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS 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 23684077 ↗MalfunctionNov 10, 2025Unable 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 23511718 ↗MalfunctionNov 4, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS 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 23466296 ↗MalfunctionAug 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854887 ↗MalfunctionAug 6, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE COMPLAINT STATES THAT "RECEIVER REINITIALIZATION" WAS REPORTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731745 ↗MalfunctionJul 30, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 22672005 ↗MalfunctionJun 13, 2025Unable 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 22202501 ↗MalfunctionJun 5, 2025Defective Alarm; Defective Alarm
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS 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 22151838 ↗MalfunctionMay 5, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 21963549 ↗MalfunctionApr 2, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 21755763 ↗MalfunctionApr 2, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 21751947 ↗MalfunctionMar 24, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21681780 ↗MalfunctionMar 20, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 21657598 ↗MalfunctionJan 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT A DISPLAY 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 21257915 ↗MalfunctionJan 16, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT A DISPLAY 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 21172256 ↗MalfunctionJan 10, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 21132076 ↗MalfunctionDec 30, 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 21044871 ↗MalfunctionDec 13, 2024Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20929564 ↗MalfunctionOct 24, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 20526137 ↗MalfunctionOct 16, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS 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 20462762 ↗MalfunctionAug 27, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A RECEIVER REINITIALIZATION 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 20081294 ↗MalfunctionAug 14, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN OCCURRED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19984323 ↗MalfunctionAug 13, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS 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 19977646 ↗MalfunctionJul 25, 2024Unable to Obtain Readings; Unable to Obtain Readings
PRODUCT WAS PROVIDED FOR INVESTIGATION. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 19830699 ↗
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 · 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
- 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
Other Sensor, Glucose, Invasive, Non-Adjunctive devices
- Dexcom G5 Mobile Transmitter Kit (Medicare) STT-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive18,422 reports
- Dexcom Receiver MT22949Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive7,702 reports
- Dexcom G5 Mobile Replacement Receiver Kit (Medicare) STR-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive4,734 reports
- Dexcom G5 Mobile Android App SW10940Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive3,843 reports
- Dexcom G5 Mobile Receiver Kit (Medicare) STK-MC-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive1 recall494 reports
- Dexcom Receiver Kit STK-SD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive145 reports
- Dexcom Replacement Receiver Kit STR-SD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive33 reports
- Dexcom Replacement Receiver Kit (Medicare) STR-MD-001Dexcom, Inc. · Sensor, Glucose, Invasive, Non-Adjunctive27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.