Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-BLURecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10386270000115), received between Jan 26, 2017 and Mar 14, 2019 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2019Unexpected Shutdown; Unexpected Shutdown

  DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT ON (B)(6) 2019 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 8423214 ↗
• MalfunctionApr 25, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWRS 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 7457761 ↗
• MalfunctionMar 30, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED "ERR HWBAT". 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 7385422 ↗
• MalfunctionOct 17, 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 HW" ERROR. 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 6955105 ↗
• MalfunctionSep 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 ERR46. 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 6838071 ↗
• MalfunctionJun 20, 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 WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653995 ↗
• 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 ERR121. 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 6633764 ↗
• MalfunctionMay 8, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERRHWRF. 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 6552158 ↗
• MalfunctionApr 14, 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 CODE HWRF: 'CALL TECH SUPPORT DISPLAYED WITH LOUD ALARM.' 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 6493998 ↗
• MalfunctionApr 13, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DEXCOM WAS MADE AWARE ON 03/22/2017 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 REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489968 ↗
• MalfunctionMar 24, 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6433132 ↗
• MalfunctionMar 9, 2017No Audible Alarm; No Audible Alarm

  THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A MANUAL TEST WAS PERFORMED AND SPEAKER SOUNDED. 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 6393365 ↗
• MalfunctionFeb 24, 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. 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 6359174 ↗
• MalfunctionFeb 1, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERRHWRF. 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 6294852 ↗
• MalfunctionJan 26, 2017Defective Alarm; Defective 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 REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6280585 ↗

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