Dexcom G5 Touchscreen Receiver STK-SR-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20386270000327), received between Dec 1, 2017 and Oct 24, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE TEST WAS PERFORMED AND PASSED. RECEIVER BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TEST WAS PERFORMED AND PASSED. A TOUCHSCREEN MANUAL BUTTON TEST WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998689 ↗
• MalfunctionOct 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885622 ↗
• MalfunctionAug 22, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE RECEIVER DISPLAY WAS FROZEN. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597766 ↗
• MalfunctionJul 19, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356408 ↗
• MalfunctionJul 11, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300472 ↗
• MalfunctionJun 2, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PRODUCT WAS EVALUATED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. A RECEIVER TOUCH SCREEN MANUAL TEST WAS PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050122 ↗
• MalfunctionMay 11, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914288 ↗
• MalfunctionJan 5, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ERROR ICON DISPLAYED OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102132 ↗
• MalfunctionJan 29, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, PATIENT EXPERIENCED A LOSS OF CONNECTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. : NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7226242 ↗
• MalfunctionJan 9, 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. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175164 ↗
• MalfunctionDec 20, 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. THE RECEIVER HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7136750 ↗
• MalfunctionDec 20, 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 COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7135742 ↗
• MalfunctionDec 18, 2017Defective Alarm; Defective Alarm

  DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT VIBRATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER WAS CHARGED AND WILL BOOT. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED, FINDING NO ERRORS RELATED TO THE COMPLAINT WITHIN THE INVESTIGATION WINDOW. A RECEIVER FUNCTIONAL TEST WAS PERFORMED AND PASSED. MANUAL "TRY IT" TESTING AND WAS PERFORMED AND PASSED VIBRATOR MODE. THE REPORTED EVENT OF AN INTERMITTENT VIBRATION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126968 ↗
• MalfunctionDec 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE PATIENT WAS NOT GETTING VALUES ON THE RECEIVER. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. A ROOT CAUSE WAS NOT DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074459 ↗

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
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• 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