Dexcom G6 Professional System STP-PR-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00386270001092), received between Feb 19, 2021 and Sep 12, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (6 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744807 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. 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 23398714 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. 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 22638563 ↗
• MalfunctionJul 28, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638494 ↗
• MalfunctionJul 28, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632079 ↗
• MalfunctionMay 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 22032606 ↗
• MalfunctionMay 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 22032567 ↗
• MalfunctionMar 11, 2024Break; Break

  SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 18874432 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024. IT WAS INDICATED THAT THE PATIENT REMOVED THE TRANSMITTER FROM THE SENSOR POD BEFORE REMOVING THE SENSOR FROM THE BODY, WHICH IS MISUSE OF THE DEVICE. NO PRODUCT 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 18856805 ↗
• MalfunctionNov 21, 2023Break; Break

  SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18185629 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEXCOM WAS MADE AWARE ON (B)(6) 2023, THAT ON (B)(6) 2023 , THE PATIENT EXPERIENCED A SKIN REACTION. IT WAS REPORTED THAT THE PHYSICIAN THAT THE UNKNOWN PATIENT EXPERIENCED A SKIN ISSUE WITH LIPOATROPHY FROM WEARING THE G6 SENSOR. THE EVENT OCCURRED AN UNSPECIFIED NUMBER OF DAYS AFTER THE SENSOR HAD BEEN INSERTED. THE PHYSICIAN DECLINED TO PROVIDE ADDITIONAL INFORMATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17647758 ↗
• MalfunctionFeb 27, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444705 ↗
• MalfunctionFeb 24, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439847 ↗
• MalfunctionFeb 23, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A TRANSMITTER VOLTAGE TEST WAS PERFORMED AND PASSED. A NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS/BIN FILE WAS PERFORMED AND SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED AS THE ALLEGATION WAS NOT FOUND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430151 ↗
• MalfunctionFeb 23, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429629 ↗
• MalfunctionFeb 8, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327385 ↗
• MalfunctionJan 17, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16190699 ↗
• MalfunctionJan 11, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143211 ↗
• MalfunctionDec 13, 2022Wireless 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 15973468 ↗
• MalfunctionDec 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A G6 PRO DEVICE THAT STOPPED WORKING OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS GREATER THAN AN HOUR WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. THE REPORTED EVENT OF A SENSOR THAT STOPPED WORKING IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS GREATER THAN AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961846 ↗
• MalfunctionSep 30, 2022Imprecision; Imprecision

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 100 POINTS. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514709 ↗
• MalfunctionSep 27, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN 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 15494507 ↗
• MalfunctionAug 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE NOT GETTING NOT A FULL SENSOR SESSION OF DATA OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2022. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS GREATER THAN AN HOUR WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO SIGNAL LOSS DUE TO THE TRANSMITTER AND APP WERE NOT BEING ABLE TO RESTORE THE CONNECTION. THE REPORTED EVENT OF THE DEVICE NOT GETTING NOT A FULL SENSOR SESSION OF DATA IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS GREATER THAN AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294958 ↗
• MalfunctionFeb 19, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED ON 01-20-2021. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 100 POINTS. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349952 ↗