Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US STK-CR-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20386270000181), received between Feb 15, 2017 and Jul 16, 2019 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 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 8793798 ↗
• MalfunctionJun 14, 2018Defective Alarm; Defective Alarm

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604129 ↗
• MalfunctionMay 21, 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 CALL TECH SUPPORT". 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 7530704 ↗
• MalfunctionMay 11, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE RECEIVER DISPLAYED AN ERRHWBBT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND HARDWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507765 ↗
• MalfunctionApr 11, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWBBT 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 7423060 ↗
• MalfunctionApr 4, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERRHWBBT 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 7396622 ↗
• MalfunctionJan 9, 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. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND HARDWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175648 ↗
• MalfunctionDec 4, 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 7081566 ↗
• MalfunctionNov 27, 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 HWBBT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF AN ERROR ICON DISPLAY COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061481 ↗
• MalfunctionJun 28, 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 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 6674910 ↗
• MalfunctionJun 21, 2017Defective Alarm; Defective Alarm

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6657133 ↗
• MalfunctionMay 10, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER WAS CHARGED AND IT PASSED. THE RECEIVER LOG WAS REVIEWED HARDWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6557438 ↗
• MalfunctionApr 27, 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 6526620 ↗
• MalfunctionApr 12, 2017Wireless Communication Problem; Wireless Communication Problem

  THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER WAS CHARGED AND REBOOTED. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND PASSED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487504 ↗
• MalfunctionMar 16, 2017Defective Alarm; Defective Alarm

  THE COMPLAINT DEVICE 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 AN INTERMITTENT AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6410121 ↗
• MalfunctionMar 14, 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 6402377 ↗
• MalfunctionFeb 27, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED, FINDING NO ERRORS RELATED TO THE COMPLAINT. A GLOBAL RECEIVER FUNCTIONAL TEST WAS PERFORMED, AND IT PASSED THE SPEAKER TESTS. MANUAL TESTING WAS PERFORMED AND PASSED. DROP TESTING WAS PERFORMED AND PASSED. THE RECEIVER CASE WAS OPENED FOR AN INTERIOR INSPECTION, AND THE NEW SPEAKER WAS INSTALLED. SPEAKER RESISTANCE WAS MEASURED AND PASSED. 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 6363261 ↗
• MalfunctionFeb 22, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND SCREEN ERROR ALARMS AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6350645 ↗
• MalfunctionFeb 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 ERROR 67. 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 6341583 ↗
• MalfunctionFeb 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR126. 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 6334662 ↗

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-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
• 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