Dexcom G4 Platinum Transmitter Kit US STT-GL-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,935 adverse event reports that list this exact device (DI 10386270000047), received between Aug 11, 2015 and May 22, 2024 — classified as 12 injuries, 1,923 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (1,581 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 1,935 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024No Device Output; No Device Output

  SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373678 ↗
• MalfunctionFeb 17, 2021Communication or Transmission Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338499 ↗
• MalfunctionJan 11, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11146697 ↗
• MalfunctionDec 9, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10977220 ↗
• MalfunctionNov 10, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10816262 ↗
• MalfunctionOct 30, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10763336 ↗
• MalfunctionOct 29, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10756332 ↗
• MalfunctionOct 22, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. REPORTEDLY, THE CUSTOMER WAS AROUND A RADIO WAVE TOWER, AND CONNECTION IS REGAINED ONCE LEAVING. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10718050 ↗
• MalfunctionOct 21, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. REPORTEDLY, THE CUSTOMER WAS ATTEMPTING TO USE AN INCOMPATIBLE TRANSMITTER. CUSTOMER EDUCATED ON THE INCOMPATIBILITY OF THE TRANSMITTER WITH THE CUSTOMER'S CURRENT SOFTWARE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10711644 ↗
• MalfunctionOct 6, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE MORE THAN 6 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. TANDEM CUSTOMER TECHNICAL SUPPORT INSTRUCTED CUSTOMER TO USE A NEW TRANSMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10638180 ↗
• MalfunctionSep 16, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10541264 ↗
• MalfunctionSep 15, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE MORE THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. TANDEM CUSTOMER TECHNICAL SUPPORT INSTRUCTED CUSTOMER TO USE A NEW TRANSMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10537501 ↗
• MalfunctionAug 7, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. REPORTEDLY, THERE WAS OBSTRUCTION BETWEEN THE PUMP AND THE TRANSMITTER. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10380107 ↗
• MalfunctionAug 4, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE LONGER THAN 90 DAYS; CUSTOMER SUPPORT INSTRUCTED CUSTOMER TO CHANGE TRANSMITTER. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362448 ↗
• MalfunctionJul 30, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347774 ↗
• MalfunctionJul 16, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10283421 ↗
• MalfunctionJul 9, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE LONGER THAN 6 MONTHS. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10253418 ↗
• MalfunctionJul 8, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10246640 ↗
• MalfunctionJul 2, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT INTERMITTENT INVALID TRANSMITTER ID ALERTS OCCURRED. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE INITIATED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10224297 ↗
• MalfunctionJul 1, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10219435 ↗
• MalfunctionJun 19, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR AN UNSPECIFIED DURATION OF TIME. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10176081 ↗
• MalfunctionJun 18, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10168357 ↗
• MalfunctionJun 5, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125069 ↗
• MalfunctionMay 21, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10079218 ↗
• MalfunctionMay 20, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10075251 ↗

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