Dexcom G5 Mobile Replacement Receiver Kit (Medicare) STR-MC-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,734 adverse event reports that list this exact device (DI 00386270000613), received between Jul 12, 2017 and Dec 29, 2020 — classified as 43 injuries, 4,691 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (1,025 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 4,734 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11086823 ↗
• MalfunctionNov 2, 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 10770585 ↗
• MalfunctionSep 9, 2020Unexpected Shutdown; Unexpected Shutdown

  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 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 10507699 ↗
• MalfunctionAug 31, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. 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 ALL RELEVANT TESTING. 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 10471362 ↗
• MalfunctionAug 10, 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 10387212 ↗
• 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 10308485 ↗
• MalfunctionJul 9, 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 10253257 ↗
• MalfunctionJul 6, 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 10233315 ↗
• MalfunctionJun 30, 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 10212627 ↗
• MalfunctionJun 22, 2020Wireless 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 10178691 ↗
• MalfunctionJun 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 10128821 ↗
• MalfunctionJun 8, 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 10128677 ↗
• MalfunctionJun 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 10128621 ↗
• MalfunctionJun 4, 2020Wireless 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 10121411 ↗
• MalfunctionJun 4, 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 10120909 ↗
• MalfunctionJun 2, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE RECEIVER WAS MISSING DATA. DATA WAS PRESENT IN THE CLOUD FOR INVESTIGATION, FOUND LOSS OF CONNECTION GREATER THAN 3 HOURS WITHIN THE INVESTIGATION WINDOW, THE CONFIRMATION OF THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT OF THE RECEIVER MISSING DATA IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS GREATER THAN THREE HOURS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10109899 ↗
• MalfunctionMay 28, 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 10099298 ↗
• MalfunctionMay 28, 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 10099267 ↗
• MalfunctionMay 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 10040197 ↗
• MalfunctionMay 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 10038683 ↗
• MalfunctionMay 4, 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 10020398 ↗
• MalfunctionApr 29, 2020Wireless 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 10010619 ↗
• MalfunctionApr 28, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT UNEXPECTED RECEIVER SHUTDOWN OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED ALL RELEVANT TESTING. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND NO DATA IN THE INVESTIGATION WINDOW RELATED TO THE COMPLAINT WAS FOUND. THE ALLEGATION WAS NOT CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005171 ↗
• MalfunctionApr 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 9987489 ↗
• MalfunctionApr 21, 2020Wireless 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 9983086 ↗

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