Dexcom G6 Sensor Applicator Assembly 9500-45Recalls & reported problems
Dexcom, Inc. · G6 Sensor Applicator Assembly · Class 2
Quick summary
This is a Dexcom G6 sensor applicator. Its reports mostly describe glucose readings that are imprecise or differ from blood glucose meter readings, early sensor-expiry warnings and parts coming loose. There are 114,635 reports, including 4 deaths and 4,589 injuries. One recall, started in February 2020, is closed: a cancer drug, hydroxyurea, may make glucose readings falsely high. Reports dropped to 2,651 in the last 12 months, from 11,217 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
- 114,678
- Deaths reported
- 4
- Injuries reported
- 4,587
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 114,678 adverse event reports that list this exact device (DI 00386270000255), received between Jun 5, 2017 and Sep 30, 2026 — classified as 4 deaths, 4,587 injuries, 110,087 malfunctions.
The most frequently reported specific device problem is “Imprecision” (40,878 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Feb 3, 2020Terminated
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
Z-1562-2020 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Imprecision40,878
- Premature End-of-Life Indicator23,315
- Incorrect, Inadequate or Imprecise Result or Readings18,706
- Detachment of Device or Device Component10,114
- Appropriate Device Problem Term/Code Not Available4,183
- Low Readings3,520
- Retraction Problem3,204
- Break3,102
Patient problems
- No Consequences Or Impact To Patient43,250
- No Clinical Signs, Symptoms or Conditions37,132
- Hyperglycemia26,174
- Hypoglycemia5,139
- Foreign Body In Patient1,071
- Loss of consciousness1,052
- Dizziness751
- Fatigue611
Recent adverse event reports
The 25 most recent of 114,678 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026High 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 an off-label insertion site 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 B zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949497 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940995 ↗MalfunctionSep 29, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50940375 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938748 ↗MalfunctionSep 28, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50926187 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into an off-label insertion site, on (b)(6) 2026. 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. 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 50917775 ↗MalfunctionSep 25, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906148 ↗MalfunctionSep 25, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906035 ↗MalfunctionSep 25, 2026Low Readings
It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred OCCASIONALLY between on (b)(6) 2026. The sensor was inserted into the Abdomen on (b)(6) 2026. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50898660 ↗MalfunctionSep 25, 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 abdomen on (b)(6) 2026. No data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50893352 ↗MalfunctionSep 24, 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 an off-label insertion site, on (b)(6)2026. It was indicated that the patient entered BG values outside the 40¿400 mg/dL (2.2¿22.2 mmol/L) range, which is misuse of the device. 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 C zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50890241 ↗InjurySep 24, 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 arm on (b)(6) 2026, which is off-label usage of the device. On the same day, it was reported that the patient experienced a CGM inaccuracy issue. Following completion of the sensor warm-up period and placement of a G6 sensor, the patient believed the sensor readings were inaccurate. The CGM reportedly displayed a glucose value of 95 mg/dL, which later decreased to approximately 70 mg/dL. Between approximately 11:00 AM and 12:00 PM, the patient administered a Gvoke HypoPen glucagon injection, consumed honey, and ate a doughnut in response to the low CGM readings; however, the patient reported that the sensor values did not change following these interventions. At approximately 1:30 PM, the patient developed a headache and presented to a nearby fire department because no blood glucose meter was available. An Emergency medical services (EMS) obtained a fingerstick BG measurement, which reportedly showed 289 mg/dL, while the CGM reading was reportedly 188 mg/dL at the same time. Following the glucose measurement, the patient returne
Patient problems: Headache; Hyperglycemia
MAUDE report 50886754 ↗MalfunctionSep 24, 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 Abdomen 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 falls within the C zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50883157 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the abdomen on (b)(6) 2026. 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. 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 50871598 ↗MalfunctionSep 23, 2026High 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) 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 falls within the C zone of the Parkes Error Grid. No serious or prolonged patient harm or medical intervention was reported.
Patient problems: Alteration in Body Temperature; Diaphoresis; Dizziness; Hypoglycemia; Malaise
MAUDE report 50866911 ↗MalfunctionSep 22, 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 abdomen on 08/29/2026. No data was provided for evaluation. The allegation and the probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50855533 ↗MalfunctionSep 22, 2026High Readings
It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred frequently between (b)(6)2026. The sensor was inserted into the abdomen on (b)(6)2026. Data was provided for investigation. The allegation was confirmed due to the finding of inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred foccasionally within the investigation window. The probable cause of the inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter could not be determined. 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: Hypoglycemia
MAUDE report 50854868 ↗MalfunctionSep 21, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50848590 ↗MalfunctionSep 21, 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 abdomen on (b)(6) 2026. No data was provided for evaluation. The allegation and the probable cause could not be determined. The reported glucose values fall within the D zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50846621 ↗MalfunctionSep 21, 2026High Readings
Patient problems: Hypoglycemia
MAUDE report 50845752 ↗MalfunctionSep 21, 2026High Readings
It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred frequently between 8/28/2026 and 8/31/2026. The sensor was inserted into an off-label insertion site, on (b)(6) 2026. Data was provided for investigation. The allegation was confirmed due to the finding of inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred rarely within the investigation window. The probable cause of the inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter could not be determined. 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 B zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842720 ↗MalfunctionSep 19, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50831757 ↗MalfunctionSep 18, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50830919 ↗MalfunctionSep 18, 2026Wireless Communication Problem
It was reported that no reading occurred. The sensor was inserted into the abdomen on(b)(6) 2026. 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 no reading 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 50820794 ↗MalfunctionSep 18, 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 abdomen 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. However, the data investigation found a difference in values that falls within the C zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50817170 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
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- 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.