Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10386270000078), received between Feb 16, 2017 and Jun 19, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE RECEIVER CEASED TO FUNCTION. 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 8713740 ↗
• MalfunctionFeb 27, 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: ERROR. 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 7301725 ↗
• MalfunctionFeb 22, 2018Use of Device Problem; Device Displays Incorrect Message; Use of Device Problem; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN ERROR ICON WAS DISPLAYED ON THE RECEIVER. REPORTEDLY, THE ADULT PATIENT IS USING A PEDIATRIC 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. LABELING INDICATES: THE DEXCOM SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290668 ↗
• 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 7185927 ↗
• MalfunctionJul 18, 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 ERRHWBAT. 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 6722824 ↗
• MalfunctionMay 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 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 6534996 ↗
• MalfunctionMay 1, 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 6534083 ↗
• MalfunctionApr 6, 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 6464185 ↗
• MalfunctionApr 5, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO VIBRATION. NO ADDITIONAL EVENT OR PATIENT 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; HOWEVER, NO ISSUES RELATED TO THE CUSTOMER'S COMPLAINT WERE OBSERVED IN THE COURSE OF THE LOG REVIEW. GLOBAL RECEIVER FUNCTIONAL TEST WAS PERFORMED AND FAILED, BUT RESULTS ARE NOT RELATED TO THE REPORTED EVENT. A MANUAL SOUND DROP TEST WAS PERFORMED AND PASSED. THE REPORTED EVENT OF NO VIBRATION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6462389 ↗
• MalfunctionApr 5, 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 6462386 ↗
• MalfunctionMar 29, 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 DID NOT SOUND. 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 6442893 ↗
• MalfunctionFeb 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 6337991 ↗

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