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Dexcom G6 Receiver STK-FE-001Recalls & reported problems

Dexcom, Inc. · G6 Falcon Receiver DME · Class 2

Quick summary

This Dexcom G6 receiver is a handheld display for readings from a body-worn glucose sensor. Many of its 188 reports describe unexpected resets or shutdowns, and some describe alarms that did not sound. Most reports say no patient was affected. There is 1 injury report and no deaths. No recalls name this device. Reports fell from 100 in the year before to 51 in the latest year.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
191
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 00386270002860), received between Jan 5, 2024 and Sep 24, 2026 — classified as 1 injury, 190 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (83 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 3 reportsJun 2024: 4 reportsJul 2024: 2 reportsAug 2024: 4 reportsSep 2024: 9 reportsOct 2024: 9 reportsNov 2024: 8 reportsDec 2024: 7 reportsJan 2025: 5 reportsFeb 2025: 4 reportsMar 2025: 9 reportsApr 2025: 7 reportsMay 2025: 6 reportsJun 2025: 9 reportsJul 2025: 5 reportsAug 2025: 17 reportsSep 2025: 11 reportsOct 2025: 12 reportsNov 2025: 10 reportsDec 2025: 10 reportsJan 2026: 4 reportsFeb 2026: 5 reportsMar 2026: 5 reportsApr 2026: 6 reportsMay 2026: 3 reportsJun 2026: 1 reportsJul 2026: 5 reportsAug 2026: 2 reportsSep 2026: 3 reportsOct 2026: 0 reports20242025202617
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Inappropriate or Unexpected Reset83
  • Unexpected Shutdown50
  • No Audible Alarm19
  • Defective Alarm14
  • Display or Visual Feedback Problem12
  • Wireless Communication Problem10
  • Appropriate Device Problem Term/Code Not Available1
  • Low Audible Alarm1

Patient problems

  • No Clinical Signs, Symptoms or Conditions190
  • Hypoglycemia1

Recent adverse event reports

The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Inappropriate or Unexpected Reset

    It was reported that a receiver reinitialization occurred. Data was received but not investigated as data will not confirm the issue. 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 50885449 ↗
  • MalfunctionSep 23, 2026Inappropriate or Unexpected Reset

    It was reported that a receiver reinitialization occurred. Data was received but not investigated as data will not confirm the issue. 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 50872872 ↗
  • MalfunctionSep 23, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50862941 ↗
  • MalfunctionAug 25, 2026Inappropriate or Unexpected Reset

    It was reported that a receiver reinitialization occurred. Data was received but not investigated as data will not confirm the issue. 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 50436469 ↗
  • MalfunctionAug 17, 2026Unexpected Shutdown

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50287599 ↗
  • MalfunctionJul 28, 2026Inappropriate or Unexpected Reset

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50057620 ↗
  • MalfunctionJul 16, 2026Inappropriate or Unexpected Reset

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25845676 ↗
  • MalfunctionJul 13, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25805841 ↗
  • MalfunctionJul 7, 2026Defective Alarm

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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 25738908 ↗
  • MalfunctionJul 7, 2026Unexpected Shutdown

    IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 25738342 ↗
  • MalfunctionJun 26, 2026Unexpected Shutdown

    IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 25636684 ↗
  • MalfunctionMay 21, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION 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 25247998 ↗
  • MalfunctionMay 7, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION 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 25117608 ↗
  • MalfunctionMay 6, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 25096860 ↗
  • MalfunctionApr 29, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION 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 25034237 ↗
  • MalfunctionApr 29, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION 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 25031108 ↗
  • MalfunctionApr 22, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN (B)(6) 2026. 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 24955986 ↗
  • MalfunctionApr 13, 2026Defective Alarm

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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 24866876 ↗
  • MalfunctionApr 13, 2026Unexpected Shutdown

    IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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 24863124 ↗
  • MalfunctionApr 7, 2026No Audible Alarm

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO USB CONNECTOR DAMAGE. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND FAILED. THE SPEAKER/VIBRATOR RESISTANCE WAS MEASURED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. PERFORMANCE DATA WAS REVIEWED. AN ALERT/NOTIFICATION SETTINGS ISSUE WAS NOT FOUND 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 24805656 ↗
  • MalfunctionMar 30, 2026Defective Alarm

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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 24709101 ↗
  • MalfunctionMar 26, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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 24702473 ↗
  • MalfunctionMar 16, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT A DISPLAY ISSUE 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 24611744 ↗
  • MalfunctionMar 9, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 24551898 ↗
  • MalfunctionMar 2, 2026Inappropriate or Unexpected Reset

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 24484317 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.