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

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 20386270000082), received between Jan 27, 2017 and Mar 15, 2019 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (11 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2019Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, 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 8425645 ↗
• MalfunctionDec 19, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN "ERR 67" 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 8179740 ↗
• MalfunctionSep 10, 2018Unable to Obtain Readings; Unable to Obtain Readings

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERR31907 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 7861593 ↗
• MalfunctionFeb 26, 2018No Audible Alarm; No Audible Alarm

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297412 ↗
• MalfunctionDec 14, 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 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 7117634 ↗
• MalfunctionDec 14, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 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 CONNCECTION COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117567 ↗
• MalfunctionDec 13, 2017Defective Alarm; Defective Alarm

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7115560 ↗
• MalfunctionDec 1, 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 ERR67. 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 7076220 ↗
• MalfunctionNov 10, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7021319 ↗
• MalfunctionOct 8, 2017No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON 09/17/2017 THAT ON (B)(6) THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED NO AUDIO OUTPUT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927829 ↗
• 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 ERR HWRS. 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 6907585 ↗
• MalfunctionJul 25, 2017Wireless Communication Problem; Wireless Communication Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6742727 ↗
• MalfunctionJul 6, 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 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 6690042 ↗
• MalfunctionJun 12, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERRHWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6635202 ↗
• MalfunctionMay 5, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548752 ↗
• MalfunctionMay 3, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERRHWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6541508 ↗
• MalfunctionMay 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWBAT . NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6538946 ↗
• MalfunctionApr 19, 2017No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. A MANUAL TEST WAS PERFORMED AND FAILED. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6505531 ↗
• MalfunctionMar 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERRHWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6414683 ↗
• MalfunctionMar 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWBAT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6412045 ↗
• MalfunctionMar 6, 2017Device Inoperable; Device Inoperable

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF THE RECEIVER CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6381600 ↗
• MalfunctionMar 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWRF. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6373333 ↗
• MalfunctionFeb 28, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017 THE RECEIVER DISPLAYED ERROR 121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE 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 6364136 ↗
• MalfunctionFeb 17, 2017No Audible Alarm; No Audible Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. A MANUAL TEST WAS PERFORMED AND FAILED. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6341763 ↗
• MalfunctionFeb 9, 2017Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6318360 ↗

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