Dexcom G4 Platinum Sensor Kit 1PK US STS-GL-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10386270000016), received between Feb 4, 2016 and Feb 24, 2017 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE OF 01/28/2017, THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION TO THE SENSOR. THE SENSOR WAS INSERTED ON THE ABDOMEN ON (B)(6) 2017. THE PATIENT STATED THAT UPON INSERTION, THE SITE IMMEDIATELY STARTED ITCHING. LATER THAT DAY, THE PATIENT COMPLAINED THAT THE SITE ITCHED AND THE PATIENT'S MOTHER NOTICED LITTLE BUMPS AROUND THE ADHESIVE . ON (B)(6) 2017, THE PATIENT'S MOTHER REMOVED THE SENSOR TO DISCOVER THE SKIN REACTION WHICH WAS RED, WARM, AND HAS LITTLE BUMPS AROUND THE SENSOR INSERTION SITE. THE REACTION WAS A QUARTER SIZED. THE PATIENT'S MOTHER CALLED THE DOCTOR AND WAS PRESCRIBED STEROID CREAM. AT THE TIME OF CONTACT, THE PATIENT WAS DOING FINE. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION, HOWEVER A PHOTOGRAPH WAS PROVIDED. THE REPORTED EVENT WAS CONFIRMED THROUGH THE PHOTOGRAPH. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Itching Sensation; Rash; Reaction

  MAUDE report 6358820 ↗
• InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE OF 01/28/2017, THAT ON (B)(6) 2016, THAT THE PATIENT EXPERIENCED A SKIN REACTION TO THE SENSOR. THE SENSOR WAS INSERTED ON THE LEFT SIDE OF THE ABDOMEN ON (B)(6) 2016. AFTER 4-5 HOURS OF INSERTION, THE SITE STARTED TO ITCH. AFTER 1-2 DAYS, THE PATIENT FELT A BURNING FEELING. AFTER THE 3RD DAY, THE PATIENT REMOVED THE SENSOR DUE TO THE SKIN REACTION. THE PATIENT REPORTED THAT SHE SAW HER CERTIFIED DIABETES EDUCATOR (CDE) FOR ROUTINE CHECK-UP ON (B)(6) 2016 AND MENTIONED SKIN REACTION SHE HAD IN (B)(6) 2016, WHICH HAD SCARRING ON HER ABDOMINAL AREA DUE TO THE REACTION. HER CDE RECOMMENDED SHE INSERT THE SENSORS IN ARM INSTEAD. THE AFFECTED AREA WAS TREATED WITH OVER THE COUNTER PRODUCTS, HYDROCODONE CREAM, BURN CREAM, LIQUID BENADRYL, BENADRYL CREAM, AVEENO ECZEMA CREAM, AND COCONUT OIL. AT TIME OF THE CONTACT, THE PATIENT WAS STILL HAVING THE SAME ISSUES. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION, HOWEVER A PHOTOGRAPH WAS PROVIDED. THE REPORTED EVENT WAS CONFIRMED THROUGH THE PHOTOGRAPH. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Itching Sensation; Rash; Reaction

  MAUDE report 6355146 ↗
• InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2017. THE REACTION WAS DESCRIBED AS A STRONG ITCH, REDNESS, ELEVATED SKIN, LEAVES OCCASIONAL BURN MARKS, A PERMANENT DARK MARK ON SKIN. AFFECTED AREA WAS TREATED WITH OVER-THE-COUNTER BENADRYL CREAM. AT TIME OF CONTACT, PATIENT IS STILL HAVING ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. HOWEVER, PHOTOGRAPHS WERE PROVIDED WHICH CONFIRMED THE ALLEGED MALFUNCTION. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Burn(s); Erythema; Itching Sensation; Reaction

  MAUDE report 6353339 ↗
• InjuryFeb 21, 2017Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED AT THE LEG. THE REACTION WAS DESCRIBED AS VERY RED, ITCHY, RAISED, AND GETS VERY RAW AFTER ONE (1) WEEK. AFFECTED AREA WAS TREATED WITH UNSPECIFIED TOPICAL ANTI-INFLAMMATORY AGENT. AFFECTED AREA WAS ALSO TREATED WITH AN OVER-THE-COUNTER NASAL SPRAY CALLED NASAL CORE THAT WAS PRESCRIBED (B)(6) 2017. AT TIME OF CONTACT, THE NASAL SPRAY IS REPORTED TO BE HELPING THE PATIENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE SENSOR WAS INSERTED INTO THE LEG. LABELING INDICATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.

  Patient problems: Erythema; Itching Sensation; Reaction

  MAUDE report 6347579 ↗
• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE UPPER BUTTOCKS ON (B)(6) 2017. THE REACTION WAS DESCRIBED AS AN ITCHY RED BUMP. AFFECTED AREA WAS TREATED WITH TRIAMCINOLONE CREAM PRESCRIBED ON (B)(6) 2017. AT TIME OF CONTACT, PATIENT STILL HAS REACTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Itching Sensation; Reaction

  MAUDE report 6339634 ↗
• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION AROUND THE EDGES OF THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2017. THE REACTION WAS DESCRIBED AS A DARK MARK, BURN-TYPE SCARS, MARKS THAT DO NOT GO AWAY. PATIENT DID NOT REPORT ANY TREATMENT FOR THE AFFECTED AREA. AT TIME OF CONTACT, PATIENT IS FINE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Reaction; Scarring

  MAUDE report 6339618 ↗
• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON 01/22/2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION AROUND THE EDGES OF THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2017. THE REACTION WAS DESCRIBED AS A DARK MARK, BURN-TYPE SCARS, MARKS THAT DO NOT GO AWAY. PATIENT DID NOT REPORT OF ANY TREATMENT FOR THE AFFECTED AREA. AT TIME OF CONTACT, PATIENT IS FINE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Reaction; Scarring

  MAUDE report 6339617 ↗
• InjuryFeb 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON 01/22/2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2017. THE REACTION WAS DESCRIBED AS A RASH AND WAS ITCHY. AFFECTED AREA WAS TREATED HYDROCORTISONE CREAM 1% USP PRESCRIBED ON (B)(6) 2017. AT TIME OF CONTACT, PATIENT IS GOOD. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Itching Sensation; Rash; Reaction

  MAUDE report 6336390 ↗
• InjuryFeb 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON 01/20/2017 THAT ON (B)(6) 2015, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2015. DATES ARE APPROXIMATIONS. THE REACTION WAS DESCRIBED AS ITCHY, RED BUMPS, CRACKED SKIN, AND SOME MINOR BLEEDING. AFFECTED AREA WAS TREATED WITH DESONIDE STEROID CREAM PRESCRIBED ON (B)(6) 2015. DATE OF PRESCRIPTION IS AN APPROXIMATION. AT TIME OF CONTACT, PATIENT IS RECOVERED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Reaction

  MAUDE report 6323240 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON 01/16/2017 THAT ON (B)(6) 2016, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2016. THE REACTION WAS DESCRIBED AS ITCHY, RED RASH, AND BLISTERY. AFFECTED AREA WAS TREATED WITH OVER-THE-COUNTER (OTC) BENADRYL CREAM AND OTHER OTC OINTMENTS, POSSIBLY NEOSPORIN; PATIENT'S MOTHER CANNOT RECALL THE NAMES. THE OTC OINTMENTS WERE RECOMMENDED BY PATIENT'S ENDOCRINOLOGIST ON (B)(6) 2016. AT TIME OF CONTACT, PATIENT HAS SKIN REACTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Itching Sensation; Reaction

  MAUDE report 6306121 ↗
• InjuryFeb 3, 2017Break; Break

  DEXCOM WAS MADE AWARE ON 01/05/2017, THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A BROKEN SENSOR WIRE THAT REMAINED UNDER THE SKIN. THE SENSOR WAS INSERTED IN THE PATIENT'S ABDOMEN ON (B)(6) 2016. PATIENT'S MOTHER REPORTED A MASS ON THE SKIN WHERE THE SENSOR WAS INSERTED. ON (B)(6) 2016, THE PATIENT SAW HIS DOCTOR WHO REFERRED HIM TO GET AN ULTRASOUND AT THE HOSPITAL. ON (B)(6) 2016, THE PATIENT GOT AN ULTRASOUND WHICH SHOWED A POSSIBLE SENSOR FRAGMENT ABOUT 1 CM LONG. AN X-RAY WAS ALSO TAKEN, HOWEVER RESULTS WERE NOT AVAILABLE AT THE TIME OF CONTACT. AT THE TIME OF CONTACT, THE PATIENT'S CURRENT CONDITION WAS GOOD. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6301147 ↗
• InjuryFeb 3, 2017Invalid Sensing; Invalid Sensing

  DEXCOM WAS MADE AWARE ON 01/06/2017, THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER AND AN ADVERSE EVENT THAT OCCURRED. THE PATIENT'S MOTHER INDICATED THAT THE CGM DISPLAYED A VALUE OF 55 MG/DL COMPARED TO BG METER VALUE OF 34 MG/DL. THE PATIENT'S MOTHER STATED THAT THE PATIENT HAD DROPPED FROM 64 MG/DL WITH GLUCOSE AND CRACKERS IN A MATTER OF 10 MINUTES. THE PATIENT WAS GIVEN GLUCOSE GEL AND HER BLOOD SUGAR WENT BACK UP. ADDITIONALLY, THE PATIENT'S MOTHER STATED THAT THE PATIENT'S BLOOD SUGAR SHOT UP AFTER THE EVENT AND THEREFORE, WAS GIVEN INSULIN TO GET IT TO COME BACK DOWN. THE PATIENT WAS FEELING BETTER WITHIN A COUPLE OF HOURS. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED ISSUE OF INACCURACIES BETWEEN CGM AND FS VALUES WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Hypoglycemia

  MAUDE report 6300924 ↗
• InjuryFeb 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION UNDER THE SENSOR PATCH. THE SENSOR WAS INSERTED AT THE ABDOMEN ON 01/05/2017. THE REACTION WAS DESCRIBED AS SMALL RED BUMPS THAT ITCH. AFFECTED AREA WAS TREATED WITH ATARAX OINTMENT PRESCRIBED FOR A PREVIOUS REACTION. DATE OF PRESCRIPTION IS NOT KNOWN. AT THE TIME OF CONTACT, PATIENT IS FINE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Erythema; Itching Sensation; Reaction

  MAUDE report 6295105 ↗
• MalfunctionAug 24, 2016Component Missing; Component Missing

  DEXCOM WAS MADE AWARE ON (B)(6) 2016 , TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION IS UNKNOWN ON (B)(6) 2016. THERE WAS NO REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5902056 ↗
• InjuryAug 22, 2016Detachment Of Device Component; Detachment Of Device Component

  DEXCOM WAS MADE AWARE ON 07/29/2016, TO REPORT A DETACHED SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ABDOMEN ON THE (B)(6) 2016. PATIENT STATED THAT THE SENSOR WIRE WAS UNDER HIS SKIN. THE PATIENT WENT TO A MINOR EMERGENCY CLINIC ON (B)(6) 2016. AN ANTEROPOSTERIORLY X-RAY WAS PERFORMED OF THE ABDOMEN AND NOTHING UNUSUAL WAS FOUND. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5895153 ↗
• MalfunctionAug 22, 2016Component Missing; Component Missing

  DEXCOM WAS MADE AWARE ON (B)(6) 2016 , TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ABDOMEN ON THE (B)(6) 2016. THERE WAS NO REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5895151 ↗
• MalfunctionFeb 4, 2016Fracture; Fracture

  PATIENT CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT A BROKEN SENSOR WIRE OCCURRED ON (B)(6) 2016. IT WAS STATED THAT THE PATIENT BELIEVES A PORTION OF THE SENSOR WIRE MAY HAVE BROKEN OFF AND IS LEFT UNDER THE SKIN. IT WAS ALSO STATED THAT THE INSERTION SITE IS A LITTLE WARM. THE SENSOR INSERTION WAS AT THE ABDOMEN ON (B)(6) 2016. NO ADDITIONAL EVEN TO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 5411517 ↗

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