Dexcom G4 PlatinumRecalls & reported problems across all models

We found 41 models of Dexcom G4 Platinum by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 119,308 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2015 and May 22, 2024 — classified as 3 deaths, 3,079 injuries, 116,224 malfunctions.

The most frequently reported specific device problem is “Imprecision” (48,084 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Dexcom G4 Platinum recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 3, 2020Terminated

   The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

   Z-1561-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 3, 2020Terminated

   The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

   Z-1560-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Dexcom G4 Platinum problems

Dexcom G4 Platinum models

41 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dexcom G4 Platinum Sensor 9500-27

  Sensor, Glucose, Invasive
  2 recalls2 deaths99,426 reports
• Dexcom G4 SBT Transmitter 9438-05

  Sensor, Glucose, Invasive
  1 death9,041 reports
• Dexcom G4 Global Transmitter 9438-01

  Sensor, Glucose, Invasive
  2,205 reports
• Dexcom G4 Platinum Transmitter Kit US STT-GL-003

  Sensor, Glucose, Invasive
  1,935 reports
• Dexcom G4 PLATINUM Receiver with Share Kit US STK-DR-001

  Sensor, Glucose, Invasive
  1,533 reports
• Dexcom G4 PLATINUM Replacement Receiver with Share Kit US STR-DR-001

  Sensor, Glucose, Invasive
  977 reports
• Dexcom G4 PLATINUM Receiver with Share Kit US STK-DR-PNK

  Sensor, Glucose, Invasive
  542 reports
• Dexcom G4 PLATINUM Replacement Receiver with Share Kit US STR-DR-BLU

  Sensor, Glucose, Invasive
  435 reports
• Dexcom G4 Platinum Professional Receiver Kit STK-PU-001

  Sensor, Glucose, Invasive
  423 reports
• Dexcom G4 PLATINUM Replacement Receiver with Share Kit US STR-DR-PNK

  Sensor, Glucose, Invasive
  344 reports
• Dexcom G4 Platinum Professional Transmitter Kit US STT-PU-001

  Sensor, Glucose, Invasive
  276 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit US STK-PR-BLU

  Sensor, Glucose, Invasive
  261 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit US STK-PR-PNK

  Sensor, Glucose, Invasive
  205 reports
• Dexcom G4 Platinum Receiver STK-GL-BLU

  Sensor, Glucose, Invasive
  182 reports
• Dexcom G4 PLATINUM Receiver with Share Kit (Retail) US STK-RR-001

  Sensor, Glucose, Invasive
  177 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit US STK-PR-001

  Sensor, Glucose, Invasive
  164 reports
• Dexcom G4 PLATINUM (Pediatric) Replacement Receiver with Share Kit US STR-PR-BLU

  Sensor, Glucose, Invasive
  155 reports
• Dexcom G4 Platinum Transmitter (Retail) US STT-RX-001

  Sensor, Glucose, Invasive
  140 reports
• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-001

  Sensor, Glucose, Invasive
  126 reports
• Dexcom G4 PLATINUM (Pediatric) Replacement Receiver with Share Kit US STR-PR-PNK

  Sensor, Glucose, Invasive
  125 reports
• Dexcom G4 PLATINUM (Pediatric) Replacement Receiver with Share Kit US STR-PR-001

  Sensor, Glucose, Invasive
  116 reports
• Dexcom G4 Platinum Receiver STK-GL-PNK

  Sensor, Glucose, Invasive
  104 reports
• Dexcom G4 PLATINUM Receiver with Share Kit (Retail) US STK-RR-BLU

  Sensor, Glucose, Invasive
  60 reports
• Dexcom G4 PLATINUM Receiver with Share Kit (Retail) US STK-RR-PNK

  Sensor, Glucose, Invasive
  56 reports
• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-BLU

  Sensor, Glucose, Invasive
  54 reports
• Dexcom G4 Platinum Receiver Kit (Retail) STK-RX-001

  Sensor, Glucose, Invasive
  48 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US STK-CR-BLU

  Sensor, Glucose, Invasive
  31 reports
• Dexcom G4 Platinum Replacement Receiver Kit STR-GL-PNK

  Sensor, Glucose, Invasive
  26 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US STK-CR-PNK

  Sensor, Glucose, Invasive
  22 reports
• Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US STK-CR-001

  Sensor, Glucose, Invasive
  20 reports
• Dexcom G4 Platinum Sensor Kit 1PK US STS-GL-011

  Sensor, Glucose, Invasive
  17 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-BLU

  Sensor, Glucose, Invasive
  15 reports
• Dexcom G4 Platinum Receiver Kit (Retail) STK-RX-BLU

  Sensor, Glucose, Invasive
  14 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-001

  Sensor, Glucose, Invasive
  12 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit STK-KD-PNK

  Sensor, Glucose, Invasive
  12 reports
• Dexcom G4 Platinum Receiver Kit (Retail) STK-RX-PNK

  Sensor, Glucose, Invasive
  10 reports
• Dexcom G4 Platinum (Pedicatric) Replacement Receiver Kit STR-KD-BLU

  Sensor, Glucose, Invasive
  8 reports
• Dexcom G4 Platinum (Pedicatric) Replacement Receiver Kit STR-KD-PNK

  Sensor, Glucose, Invasive
  6 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit (Retail) STK-KX-001

  Sensor, Glucose, Invasive
  3 reports
• Dexcom G4 Platinum (Pedicatric) Receiver Kit (Retail) STK-KX-PNK

  Sensor, Glucose, Invasive
  1 report
• Dexcom G4 Platinum (Pedicatric) Replacement Receiver Kit STR-KD-001

  Sensor, Glucose, Invasive
  1 report

Recent Dexcom G4 Platinum adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionNov 23, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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 12862354 ↗
• MalfunctionSep 3, 2021Wireless Communication Problem; Wireless Communication Problem

  SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425324 ↗
• MalfunctionAug 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE SENSOR WIRE BECAME DETACHED FROM THE SENSOR. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355392 ↗
• MalfunctionJul 15, 2021Wireless 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12174002 ↗
• MalfunctionJun 16, 2021Wireless 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12011056 ↗
• MalfunctionMay 21, 2021Wireless 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11864154 ↗
• MalfunctionMay 21, 2021No 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11863186 ↗
• MalfunctionMay 1, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE COUNTS ABERRATION VIA DATA. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758628 ↗
• MalfunctionApr 29, 2021No 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11749504 ↗

Other Dexcom, Inc. products

• Dexcom G613 models · 637,302 reports · 7 recalls
• Dexcom G6 Transmitter2 models · 469,968 reports
• Dexcom G732 models · 325,909 reports · 8 recalls
• Dexcom G521 models · 206,314 reports · 1 recall
• Dexcom G7 GSS (161)4 models · 141,244 reports · 1 recall
• Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
• Dexcom G7 GSS (160)4 models · 33,558 reports
• Dexcom G5 Mobile Receiver3 models · 26,327 reports