Dexcom G4 Global Transmitter 9438-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,205 adverse event reports that list this exact device (DI 00386270000040), received between Aug 10, 2015 and Oct 27, 2020 — classified as 2,205 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (968 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 2,205 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 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 10742282 ↗
• MalfunctionOct 1, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER 1 HOUR. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. CUSTOMER WAS ABLE TO REGAIN CONNECTION WITH THE SAME TRANSMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10614265 ↗
• MalfunctionSep 3, 2020Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A SENSOR EXPIRATION ALERT OCCURRED PREMATURELY. THERE WAS NO REPORTED ADVERSE IMPACT. THE CUSTOMER REPLACED THE SENSOR TO RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10488546 ↗
• MalfunctionAug 3, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. REPORTEDLY, THE CUSTOMER REPLACED TRANSMITTER. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10355656 ↗
• MalfunctionAug 3, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED INTERMITTENT INVALID TRANSMITTER ID ALERTS. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. 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 10355637 ↗
• MalfunctionJul 30, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER 1 HOUR. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10344141 ↗
• MalfunctionJul 15, 2020Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A SENSOR EXPIRATION ALERT OCCURRED PREMATURELY. THERE WAS NO REPORTED ADVERSE IMPACT. THE CUSTOMER REPLACED THE SENSOR TO RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10276790 ↗
• MalfunctionJul 1, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED INTERMITTENT INVALID TRANSMITTER ID ALERTS. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. 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 10218511 ↗
• MalfunctionJun 17, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162632 ↗
• MalfunctionJun 16, 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 10157736 ↗
• MalfunctionJun 8, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128838 ↗
• MalfunctionJun 5, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER 1 HOUR. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. DURING A FOLLOW-UP, IT WAS REPORTED THAT ISSUE HAD BEEN RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10123903 ↗
• MalfunctionMay 21, 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 10080482 ↗
• MalfunctionMay 19, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR "SOME TIME" (EXACT TIME NOT PROVIDED). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073099 ↗
• MalfunctionMay 15, 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 10062177 ↗
• MalfunctionApr 28, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10006417 ↗
• MalfunctionApr 24, 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 9996585 ↗
• MalfunctionApr 15, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN ONE 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 9963596 ↗
• MalfunctionApr 13, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED INTERMITTENT INVALID TRANSMITTER ID ALERTS. A SENSOR SESSION WAS EVENTUALLY STARTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954956 ↗
• MalfunctionApr 9, 2020Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem

  IT WAS REPORTED THAT INTERMITTENT INVALID TRANSMITTER ID ALERTS OCCURRED. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE INITIATED. IN ADDITION, CUSTOMER REPORTED A LOSS OF CONNECTION WITH THE PUMP FOR AN UNSPECIFIED AMOUNT OF TIME. 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 9946443 ↗
• MalfunctionApr 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 THREE 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 9910296 ↗
• MalfunctionMar 30, 2020Communication or Transmission Problem; Communication or Transmission Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9898386 ↗
• MalfunctionMar 11, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER 1 HOUR. 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 9820060 ↗
• MalfunctionMar 11, 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 9818994 ↗
• MalfunctionMar 5, 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 9793813 ↗

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