Dexcom G5 Mobile Replacement Receiver Kit STR-GF-PNKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,480 adverse event reports that list this exact device (DI 20386270000266), received between Aug 17, 2016 and Jul 20, 2020 — classified as 8 injuries, 1,472 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (653 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

1. 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

Recent adverse event reports

The 25 most recent of 1,480 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Wireless 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 WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296038 ↗
• MalfunctionJun 3, 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 10114550 ↗
• 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 9935454 ↗
• MalfunctionJan 30, 2020Inappropriate 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 9647138 ↗
• MalfunctionJan 29, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. 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 9644923 ↗
• MalfunctionOct 7, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT UNEXPECTED RECEIVER SHUTDOWN OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162752 ↗
• 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 9087777 ↗
• MalfunctionAug 22, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT UNEXPECTED RECEIVER SHUTDOWN OCCURRED. PRODUCT WAS RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922736 ↗
• MalfunctionJul 19, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER BOOT WAS PERFORMED AND FAILED DUE TO RECEIVER IS IN PERPETUAL REBOOTING. THE RECEIVER CASE WAS OPENED, LOGS WERE DOWNLOADED FINDING NO DATA IN THE INVESTIGATION WINDOW. INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809407 ↗
• MalfunctionJun 24, 2019Unable 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. CHARGE AND BOOT TEST WAS PERFORMED AND PASSED. THE 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 8728355 ↗
• MalfunctionJun 7, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AN ERR 121 ERROR ICON WAS DISPLAYED. 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 8679194 ↗
• MalfunctionMay 28, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE RECEIVER CEASED TO FUNCTION. 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 8647274 ↗
• MalfunctionMay 23, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE RECEIVER CEASED TO FUNCTION. 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 8636173 ↗
• MalfunctionMay 6, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "ERR 121" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8583756 ↗
• MalfunctionMay 2, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBAT" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8573814 ↗
• MalfunctionMay 1, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBBT" ERROR AND A "CALL TECH SUPPORT" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8570576 ↗
• MalfunctionApr 18, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBBT" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8529427 ↗
• MalfunctionApr 17, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "ERR 121" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8522353 ↗
• MalfunctionApr 15, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBBT" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8514873 ↗
• MalfunctionApr 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "ERR 121" ERROR WAS DISPLAYED ON THE RECEIVER. 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 8509370 ↗
• MalfunctionMar 29, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(6) 2019 THAT ON (B)(6) 2019 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE CONFIRMATION OF THE COMPLAINT IS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466635 ↗
• MalfunctionMar 21, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN 'HWBBT' ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439621 ↗
• MalfunctionMar 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN 'ERR 121' ERROR AND A 'ERR 69' ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432804 ↗
• MalfunctionMar 18, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN ERR 121 ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428984 ↗
• MalfunctionMar 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN 'HWBBT' ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413705 ↗

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