Dexcom G4 Platinum Professional Transmitter Kit US STT-PU-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 276 adverse event reports that list this exact device (DI 50386270000045), received between Jan 11, 2016 and Jul 31, 2020 — classified as 276 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (249 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 276 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 10351511 ↗
• MalfunctionJul 8, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 10244744 ↗
• MalfunctionJun 11, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 10146424 ↗
• MalfunctionMar 30, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 9901502 ↗
• MalfunctionFeb 24, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED.  NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747885 ↗
• MalfunctionFeb 6, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 9677994 ↗
• MalfunctionDec 18, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 9491731 ↗
• MalfunctionDec 10, 2019No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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 9447542 ↗
• MalfunctionDec 4, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 9414214 ↗
• MalfunctionNov 26, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 9377760 ↗
• MalfunctionNov 6, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 9286262 ↗
• MalfunctionOct 30, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT LOSS OF CONNECTION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257771 ↗
• MalfunctionJun 13, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697100 ↗
• MalfunctionApr 10, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT LOSS OF CONNECTION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500407 ↗
• MalfunctionMar 26, 2019No Device Output; No Device Output

  DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2019. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A TRANSMITTER FAILED ERROR COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453970 ↗
• MalfunctionMar 16, 2019Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE COMPLAINT COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426795 ↗
• MalfunctionMar 6, 2019Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. 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 8397421 ↗
• MalfunctionFeb 28, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A TRANSMITTER FAILED ERROR OCCURED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE REPORTED TRANSMITTER FAILED ERROR COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379381 ↗
• MalfunctionFeb 27, 2019Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375227 ↗
• MalfunctionFeb 19, 2019No Device Output; No Device Output

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A FAILED TRANSMITTER COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352538 ↗
• MalfunctionFeb 19, 2019No Device Output; No Device Output

  DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT ON (B)(6) 2019, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A FAILED TRANSMITTER COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352537 ↗
• MalfunctionFeb 19, 2019No Device Output; No Device Output

  DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2019. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A TRANSMITTER FAILED ERROR COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352073 ↗
• MalfunctionFeb 13, 2019No Device Output; No Device Output

  DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A FAILED TRANSMITTER COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337730 ↗
• MalfunctionJan 17, 2019Wireless Communication Problem; Wireless Communication Problem

  UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE BASED ON CONFIRMATION THAT A LOSS OF CONNECTION DID NOT OCCUR. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2019-09410.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8259297 ↗
• MalfunctionJan 17, 2019Wireless Communication Problem; Wireless Communication Problem

  UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE BASED ON CONFIRMATION THAT A LOSS OF CONNECTION DID NOT OCCUR. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2019-09417.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8259295 ↗

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