G4 PLATINUM Receiver with Share Kit US STK-DR-BLURecalls & reported problems

Summary

The FDA's MAUDE database contains 670 adverse event reports that list this exact device (DI 10386270000177), received between Apr 6, 2016 and Jun 1, 2020 — classified as 3 injuries, 667 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (269 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 670 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 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 10104693 ↗
• MalfunctionFeb 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 9676064 ↗
• MalfunctionFeb 1, 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 9656432 ↗
• MalfunctionDec 11, 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 9454167 ↗
• MalfunctionDec 6, 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 9432343 ↗
• 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 9321928 ↗
• MalfunctionSep 11, 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 8995913 ↗
• MalfunctionSep 9, 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 8976045 ↗
• MalfunctionAug 1, 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 8853378 ↗
• MalfunctionAug 1, 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 8851799 ↗
• MalfunctionJul 29, 2019Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT INTERMITTENT VIBRATION 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 8837182 ↗
• MalfunctionJul 29, 2019Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT INTERMITTENT AUDIO OUTPUT 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 8837163 ↗
• MalfunctionApr 30, 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 8566770 ↗
• MalfunctionApr 25, 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 PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550320 ↗
• MalfunctionApr 17, 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 PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524782 ↗
• MalfunctionApr 12, 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 8511359 ↗
• MalfunctionFeb 6, 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 8312223 ↗
• MalfunctionJan 25, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN "HWRF" 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 8278064 ↗
• MalfunctionJan 24, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN ERR HWBBT WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS NOT 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 8273204 ↗
• MalfunctionJan 21, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAY WAS FROZEN. 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 8264813 ↗
• MalfunctionJan 18, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, AN "HW BBT" ERROR WAS DISPLAYED ON THE RECEIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262124 ↗
• MalfunctionJan 15, 2019Unexpected Shutdown; Unexpected Shutdown

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER CEASED TO FUNCTION. 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 8248677 ↗
• MalfunctionJan 7, 2019No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THE RECEIVER HAD NO AUDIO OUTPUT. IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS USING AN ADULT RECEIVER. LABELING INDICATES: THE DEXCOM G4 SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER HAVING NO AUDIO OUTPUT COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224799 ↗
• MalfunctionDec 20, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN "HWBAT" 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 8185066 ↗
• MalfunctionDec 12, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERR 224 WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS NOT 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 8156773 ↗

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