Dexcom G4 Platinum Transmitter (Retail) US STT-RX-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 40386270000048), received between Jan 26, 2017 and Jun 29, 2023 — classified as 5 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (112 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 140 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, DRAINAGE, AND A SCAR UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. THERE WAS DRAINAGE AT THE REACTION SITE DURING THE HEALING STAGES AND THE SKIN BECAME ¿FLAKY¿ ONCE THE WOUND STARTED TO HEAL. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH SKIN PREP, FLONASE SPRAY, AND TEGADERM. AT THE TIME OF THE REPORT THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burning Sensation; Eczema; Erythema; Inflammation; Itching Sensation; Rash; Scar Tissue

  MAUDE report 17227477 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, DRAINAGE, AND A SCAR UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. THERE WAS DRAINAGE AT THE REACTION SITE DURING THE HEALING STAGES AND THE SKIN BECAME ¿FLAKY¿ ONCE THE WOUND STARTED TO HEAL. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH SKIN PREP, FLONASE SPRAY, AND TEGADERM. AT THE TIME OF THE REPORT THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burning Sensation; Eczema; Erythema; Fluid Discharge; Inflammation; Itching Sensation; Rash; Scar Tissue

  MAUDE report 17227464 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, DRAINAGE, AND A SCAR UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. THERE WAS DRAINAGE AT THE REACTION SITE DURING THE HEALING STAGES AND THE SKIN BECAME ¿FLAKY¿ ONCE THE WOUND STARTED TO HEAL. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH SKIN PREP, FLONASE SPRAY, AND TEGADERM. AT THE TIME OF THE REPORT THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burning Sensation; Eczema; Erythema; Fluid Discharge; Inflammation; Itching Sensation; Rash; Scar Tissue

  MAUDE report 17227462 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, DRAINAGE, AND A SCAR UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. THERE WAS DRAINAGE AT THE REACTION SITE DURING THE HEALING STAGES AND THE SKIN BECAME ¿FLAKY¿ ONCE THE WOUND STARTED TO HEAL. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH SKIN PREP, FLONASE SPRAY, AND TEGADERM. AT THE TIME OF THE REPORT THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burning Sensation; Eczema; Erythema; Fluid Discharge; Inflammation; Itching Sensation; Rash; Scar Tissue

  MAUDE report 17227169 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, DRAINAGE, AND A SCAR UNDER THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. THERE WAS DRAINAGE AT THE REACTION SITE DURING THE HEALING STAGES AND THE SKIN BECAME ¿FLAKY¿ ONCE THE WOUND STARTED TO HEAL. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH SKIN PREP, FLONASE SPRAY, AND TEGADERM. AT THE TIME OF THE REPORT THE PATIENT WAS DOING WELL. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burning Sensation; Eczema; Erythema; Fluid Discharge; Inflammation; Itching Sensation; Rash; Scar Tissue

  MAUDE report 17227157 ↗
• MalfunctionOct 20, 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 10704165 ↗
• MalfunctionJul 1, 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 10220594 ↗
• MalfunctionMay 19, 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 10070926 ↗
• MalfunctionSep 13, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9046715 ↗
• MalfunctionAug 19, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908424 ↗
• MalfunctionNov 5, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 A LOSS OF CONNECTION OCCURRED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND FAILED AS THERE WAS NO VOLTAGE. NO DATA WAS PROVIDED FOR INVESTIGATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040418 ↗
• MalfunctionOct 3, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930048 ↗
• MalfunctionSep 21, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899537 ↗
• MalfunctionAug 23, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND RESULTED IN 0 VOLTAGE. THERE WAS NO DATA LOG AVAILABLE TO CONFIRM THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR. THE COMPLAINT CONFIRMATION WAS UNABLE TO 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 7808867 ↗
• MalfunctionJul 10, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674222 ↗
• MalfunctionJul 2, 2018Wireless Communication Problem; Wireless Communication Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657024 ↗
• MalfunctionJun 14, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603383 ↗
• MalfunctionJun 11, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586486 ↗
• MalfunctionApr 18, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. THE TRANSMITTER HAS BEEN RECEIVED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND PASSED AS THE TRANSMITTER HAS VOLTAGE. NO SHARE LOG DATA WAS AVAILABLE FOR REVIEW. 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 7442302 ↗
• MalfunctionApr 13, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, 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 PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428462 ↗
• MalfunctionApr 13, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, 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 PROBABLE CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428364 ↗
• MalfunctionApr 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7404536 ↗
• MalfunctionApr 5, 2018Wireless Communication Problem; Wireless Communication Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE DEVICE HAS BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399428 ↗
• MalfunctionMar 16, 2018Wireless Communication Problem; Wireless Communication Problem

  THE TRANSMITTER WAS RETURNED FOR EVALUATION. EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A VOLTAGE TEST WAS PERFORMED AND PASSED. THE GLOBAL TRANSMITTER FINAL FUNCTIONAL TEST WAS PERFORMED AND PASSED. A PAIRING TEST WITH THE (B)(6) BLUETOOTH DEVICE WAS PERFORMED AND PASSED. THE DATA FILE WAS REVIEWED AND THERE WAS NO DATA AVAILABLE. THE REPORTED CUSTOMER COMPLAINT WAS NOT CONFIRMED BECAUSE THE DEVICE PASSED THE FUNCTIONAL TESTING. THE REPORTED ALLEGATION WAS NOT FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7346808 ↗
• MalfunctionFeb 26, 2018Imprecision; Use of Device Problem; Imprecision; Use of Device Problem

  DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2018. REPORTEDLY, THE PATIENT USED AN EXPIRED SENSOR. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: DO NOT INSERT SENSORS PAST THE EXPIRATION DATE. THE EXPIRATION DATE FORMAT IS YYYY-MM-DD. INSERT SENSORS ON OR BEFORE THE END OF THE CALENDAR DAY PRINTED ON THE SENSOR PACKAGE LABEL. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. A VOLTAGE TEST WAS PERFORMED AND IT PASSED. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297699 ↗

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