US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Recalls & reported problems
Dexcom, Inc. · G6 Retail Tx-IFU Bundle Kit · Class 2
Quick summary
This is a Dexcom G6 transmitter sold at retail. Its reports mostly describe lost wireless signal, no output from the device and connection problems. There are 76,635 reports, with no deaths and 111 injuries. No recalls name this device. Reports dropped to 8,227 in the last 12 months, from 17,750 before.
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
- 76,977
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76,977 adverse event reports that list this exact device (DI 00386270001771), received between Apr 12, 2022 and Sep 30, 2026 — classified as 117 injuries, 76,860 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (54,009 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
Most reported problems
Device problems
- Wireless Communication Problem54,009
- No Device Output21,532
- Connection Problem650
- Appropriate Device Problem Term/Code Not Available409
- Premature End-of-Life Indicator187
- Low Readings148
- Alarm Not Visible61
- Unintended Application Program Shut Down52
Patient problems
- No Clinical Signs, Symptoms or Conditions76,647
- Hyperglycemia216
- Hypoglycemia74
- Elevated Ketones/ Diabetic Ketoacidosis26
- Vomiting26
- Loss of consciousness25
- Fatigue14
- Nausea13
Recent adverse event reports
The 25 most recent of 76,977 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955085 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954990 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954764 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954743 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954292 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952897 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952282 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952274 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Loss of consciousness
MAUDE report 50952044 ↗MalfunctionSep 30, 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. 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 50952031 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952006 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951715 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951709 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951707 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951703 ↗MalfunctionSep 30, 2026No Device Output
It was reported that a transmitter battery issue occurred. Data was received but does not reflect full investigation window. 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 50951702 ↗MalfunctionSep 30, 2026No Device Output
It was reported that a transmitter battery issue occurred. It was indicated that the patient used an expired product, which is misuse of the device. Data was received but does not reflect full investigation window. 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 50951700 ↗MalfunctionSep 30, 2026No Device Output
It was reported that a transmitter battery issue occurred. It was indicated that the patient used an expired product, which is misuse of the device. Data was received but does not reflect full investigation window. 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 50951696 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951672 ↗MalfunctionSep 30, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951669 ↗MalfunctionSep 30, 2026No Device Output
It was reported that a transmitter battery issue occurred. 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 a transmitter failed error 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 50951668 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over one hour was found in connection to the reported allegation. The probable cause of the signal loss could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950764 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over one hour was found in connection to the reported allegation. The probable cause of the signal loss could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950747 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over an hour was found in connection to the reported allegation. The probable cause of the signal loss was determined to be the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950731 ↗MalfunctionSep 30, 2026No Device Output
It was reported that a transmitter battery issue occurred. Data was received but does not reflect full investigation window. 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 50950681 ↗
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- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
- FreeStyle Libre 3 Plus 78768Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1 death33,035 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.