Dexcom G4 Platinum Replacement Receiver Kit STR-GL-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 50386270000069), received between Feb 2, 2017 and Aug 21, 2020 — classified as 2 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (58 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 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 10439775 ↗
• MalfunctionOct 15, 2019Defective Alarm; Defective Alarm

  THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGED AND BOOT WERE PERFORMED AND PASSED. RECEIVER FUNCTIONAL TESTING WAS PERFORMED AND PASSED. "TRY IT" TESTING WAS PERFORMED AND PASSED. DROP TEST FOR INTERMITTENT AUDIO WAS PERFORMED AND PASSED. CASE OPENED FOR INTERIOR INSPECTION WAS PERFORMED AND PASSED. AUDIO SPEAKER RESISTANCE WAS MEASURED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERRORS 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 9193667 ↗
• MalfunctionOct 10, 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 9177516 ↗
• MalfunctionAug 6, 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. A RECEIVER CHARGE TEST WAS PERFORMED AND PASSED. A RECEIVER BOOT TEST WAS PERFORMED AND FAILED DUE TO IT WOULD NOT BOOT. FUNCTIONAL TESTS WERE 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 8864655 ↗
• MalfunctionJul 30, 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 8842370 ↗
• MalfunctionJun 21, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AN ERRPR CALL TECH SUPPORT 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 8723330 ↗
• MalfunctionJun 6, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWBB1" 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 8674154 ↗
• MalfunctionMay 29, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT 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 8650003 ↗
• MalfunctionMay 21, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627302 ↗
• MalfunctionMay 20, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626222 ↗
• MalfunctionApr 26, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWRF" 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 8554723 ↗
• MalfunctionApr 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A "HWRF" 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 8509464 ↗
• MalfunctionMar 19, 2019Unexpected Shutdown; Unexpected Shutdown

  THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO WINDOW DAMAGE. A RECEIVER CHARGE AND BOOT WAS PERFORMED AND FAILED DUE TO A CALL TECH SUPPORT ERROR MESSAGE. THE DEVICE WAS OPENED, AND AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE LOG COULD NOT BE DOWNLOADED DUE TO THE CALL TECH SUPPORT ERROR MESSAGE. 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 8433868 ↗
• MalfunctionMar 5, 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 8392446 ↗
• MalfunctionDec 31, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN "ERR 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 8206947 ↗
• MalfunctionDec 19, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, 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 8179745 ↗
• MalfunctionDec 18, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERR HWRF WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS NOT AVAILABLE FOR VALUATION. 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 8173371 ↗
• MalfunctionNov 15, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075657 ↗
• MalfunctionOct 12, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERR HW REF 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 7962332 ↗
• MalfunctionSep 14, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876804 ↗
• MalfunctionAug 21, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803031 ↗
• MalfunctionAug 10, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWBBT 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 7772485 ↗
• MalfunctionAug 6, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED "ERR HWRF". NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752848 ↗
• MalfunctionJul 31, 2018Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF INTERMITTENT AUDIO OUTPUT COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737085 ↗
• MalfunctionJul 27, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED "ERR HWBBT". NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727008 ↗

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