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Dexcom G6 Transmitter 9445-02Recalls & reported problems

Dexcom, Inc. · G6 Transmitter · Class 2

Quick summary

The 229,491 reports for this Dexcom G6 transmitter mostly describe no device output or lost wireless signal, and early battery end-of-life warnings. Most list no impact on the patient; 109 injuries and 3 deaths were reported. Many recent reports note that no product was returned, so a cause could not be determined. No recalls name this transmitter.

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
229,493
Deaths reported
3
Injuries reported
109
Recalls naming it
0

Summary

The FDA's MAUDE database contains 229,493 adverse event reports that list this exact device (DI 00386270000385), received between Apr 2, 2018 and Sep 22, 2026 — classified as 3 deaths, 109 injuries, 229,381 malfunctions.

The most frequently reported specific device problem is “No Device Output” (117,075 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: 7 reportsDec 2023: 3 reportsJan 2024: 3 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 4 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 16 reportsJun 2025: 14 reportsJul 2025: 25 reportsAug 2025: 41 reportsSep 2025: 34 reportsOct 2025: 32 reportsNov 2025: 8 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 3 reportsApr 2026: 2 reportsMay 2026: 4 reportsJun 2026: 7 reportsJul 2026: 5 reportsAug 2026: 5 reportsSep 2026: 3 reportsOct 2026: 0 reports20242025202641
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • No Device Output117,075
  • Wireless Communication Problem91,978
  • Premature End-of-Life Indicator10,146
  • Appropriate Device Problem Term/Code Not Available4,318
  • Device Displays Incorrect Message2,840
  • Connection Problem2,511
  • Inappropriate or Unexpected Reset193
  • Imprecision163

Patient problems

  • No Consequences Or Impact To Patient149,850
  • No Clinical Signs, Symptoms or Conditions83,560
  • Hypoglycemia33
  • Loss of consciousness20
  • No Known Impact Or Consequence To Patient20
  • Insufficient Information13
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
  • Elevated Ketones/ Diabetic Ketoacidosis11

Recent adverse event reports

The 25 most recent of 229,493 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50862281 ↗
  • MalfunctionSep 17, 2026No Device Output

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810370 ↗
  • MalfunctionSep 10, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50724578 ↗
  • MalfunctionAug 28, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50509626 ↗
  • MalfunctionAug 26, 2026No Device Output

    It was reported that a transmitter battery 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 50453902 ↗
  • MalfunctionAug 17, 2026Wireless Communication Problem

    It was reported that a signal loss 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 50279293 ↗
  • MalfunctionAug 13, 2026No Device Output

    It was reported that a transmitter battery 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 50234354 ↗
  • MalfunctionAug 11, 2026No Device Output

    It was reported that a transmitter battery 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 50208906 ↗
  • MalfunctionJul 29, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50069821 ↗
  • MalfunctionJul 27, 2026No Device Output

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50021678 ↗
  • MalfunctionJul 27, 2026Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50013787 ↗
  • MalfunctionJul 9, 2026No Device Output

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25763146 ↗
  • MalfunctionJul 1, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED PRODUCT, WHICH IS MISUSE OF THE DEVICE. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. 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 WAS THE TRANSMITTER AND APP WERE UNABLE TO COMPLETE A DATA TRANSFER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25685788 ↗
  • MalfunctionJun 29, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS 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 25661547 ↗
  • MalfunctionJun 23, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. 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 25598155 ↗
  • MalfunctionJun 23, 2026No Device Output

    IT WAS REPORTED THAT A TRANSMITTER BATTERY 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 25597783 ↗
  • MalfunctionJun 15, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED PRODUCT, WHICH IS MISUSE OF THE DEVICE. 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 25504657 ↗
  • MalfunctionJun 10, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS 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 25462402 ↗
  • MalfunctionJun 8, 2026No Device Output

    IT WAS REPORTED THAT A TRANSMITTER BATTERY 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 25431193 ↗
  • MalfunctionJun 1, 2026Low 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 UPPER BUTTOCKS, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2026. 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 FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Hyperglycemia

    MAUDE report 25351981 ↗
  • MalfunctionMay 14, 2026Wireless Communication Problem

    IT WAS REPORTED THAT"SIGNAL LOSS" OCCURRED. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED PRODUCT, WHICH IS MISUSE OF THE DEVICE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND THE PROBABLE CAUSE CANNOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25167111 ↗
  • MalfunctionMay 12, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED PRODUCT, WHICH IS MISUSE OF THE DEVICE. 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 25151309 ↗
  • MalfunctionMay 5, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, WHICH IS MISUSE OF THE DEVICE. 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 25089000 ↗
  • MalfunctionMay 1, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A SIGNAL LOSS 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 25062397 ↗
  • MalfunctionApr 25, 2026Wireless Communication Problem

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24991288 ↗

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