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

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 30386270000096), received between Jan 27, 2017 and Jan 3, 2020 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (31 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 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 9545514 ↗
• MalfunctionJan 2, 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 9538038 ↗
• MalfunctionNov 8, 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 9296248 ↗
• MalfunctionMay 16, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AN "ERR 224" 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 8615850 ↗
• 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 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 8158276 ↗
• MalfunctionSep 4, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWBAT 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 7842161 ↗
• MalfunctionJun 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573128 ↗
• MalfunctionMay 10, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504366 ↗
• MalfunctionFeb 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277708 ↗
• MalfunctionJan 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HW RF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7195703 ↗
• MalfunctionJan 15, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7189864 ↗
• MalfunctionJan 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7188143 ↗
• MalfunctionJan 5, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR224. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167896 ↗
• MalfunctionJan 4, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7164719 ↗
• MalfunctionDec 11, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF INTERMITTENT AUDIO OUTPUT COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106773 ↗
• MalfunctionNov 13, 2017Device Inoperable; Use of Device Problem; Device Inoperable; Use of Device Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. IT WAS REPORTED THAT THE PATIENT USED AN ALTERNATE BATTERY CHARGER. DEXCOM LABELING INDICATES: USE ONLY DEXCOM-SUPPLIED PARTS (INCLUDING CABLES AND CHARGERS). NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER CEASED TO FUNCTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7025150 ↗
• MalfunctionOct 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED AN ERR224. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908332 ↗
• MalfunctionSep 11, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4)2017, THAT ON (B)(6)2017, THE RECEIVER DISPLAYED ERR "CALL TECH SUPPORT HWRFU". NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER DATA LOG COULD NOT BE RETRIEVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS UNDETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856237 ↗
• MalfunctionSep 5, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841521 ↗
• MalfunctionAug 31, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6834141 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807787 ↗
• MalfunctionJul 27, 2017No Audible Alarm; No Audible Alarm

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER SOUNDED. THE RECEIVER WILL CHARGE AND BOOT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BECAUSE RECEIVER PASSED MANUAL SOUND TEST, SOUND WAS HEARD.THE REPORTED EVENT OF NO AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747194 ↗
• MalfunctionJul 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED A "CALL TECH SUPPORT" ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT AND DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6740250 ↗
• MalfunctionJul 24, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA RELATED TO THE ISSUE WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737006 ↗
• MalfunctionJul 13, 2017No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712265 ↗

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