Dexcom G7 GSS (161) STP-AT-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 16,695 adverse event reports that list this exact device (DI 00386270004116), received between May 10, 2024 and Sep 23, 2026 — classified as 388 injuries, 16,307 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6,405 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 16,695 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876241 ↗
• MalfunctionSep 23, 2026Break

  It was reported that a broken sensor wire 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 50871667 ↗
• MalfunctionSep 23, 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 50871337 ↗
• MalfunctionSep 21, 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 50840290 ↗
• MalfunctionSep 15, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775799 ↗
• MalfunctionSep 14, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763505 ↗
• MalfunctionSep 11, 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 50736731 ↗
• MalfunctionSep 11, 2026Wireless Communication Problem

  It was reported that signal loss occurred. The product was evaluated. An external visual inspection was performed and passed. Nordic Bluetooth Pairing Test was performed and passed. Performance data was not provided for evaluation. 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 50725516 ↗
• MalfunctionSep 10, 2026Wireless Communication Problem

  It was reported that signal loss occurred. Product was provided for investigation. An external visual inspection was performed and passed. Nordic Bluetooth Pairing Test was performed and passed. 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 50717207 ↗
• InjurySep 9, 2026Low Readings

  It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. On 08/09/2026, the patient experienced lethargy and increased urination. The patient was brought to the hospital and when a fingerstick was taken the CGM reading was LOW, and the blood glucose reading was 500 mg/dL. Ketones were high, but no specific value was reported. The patient experienced Diabetic Ketoacidosis and was treated with intravenous insulin and fluids. No further medication was reported and the patient was discharged after spending less than 24 hours at the hospital. There was no documentation of further medical evaluation or intervention. At the time of the report the patient was stable. 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 additional patient or event information is

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Lethargy; Urinary Frequency / Polyuria

  MAUDE report 50696291 ↗
• MalfunctionSep 9, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696129 ↗
• InjurySep 9, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that a wearable failure occurred. The wearable was inserted into the arm on (b)(6) 2026. The date of the event is an approximation. On 03/24/2026, the patient reported experiencing a Dexcom G7 sensor failure that displayed a "Replace Sensor" message, resulting in the loss of sensor functionality. The patient did not have a replacement sensor available at that time. The exact time of the sensor failure was unknown. No symptoms or treatment were reported immediately following the malfunction, and it was unknown whether the patient performed fingerstick blood glucose (BG) measurements after the sensor failed. On (b)(6) 2026, at an unknown time, the patient reported developing diabetic ketoacidosis (DKA) and was subsequently hospitalized. The patient stated that her blood glucose level was greater than 400 mg/dL prior to hospitalization and approximately 756 mg/dL upon arrival at the hospital. The patient reported remaining hospitalized for approximately five days, including treatment in the intensive care unit (ICU). The patient further reported that the event caused a prior bypass to fail and that she now uses a wheelchair; however, no additional information was avail

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 50694521 ↗
• InjurySep 8, 2026Incorrect, 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 frequently between (b)(6) 2026 and (b)(6) 2026. The patient was using an Omnipod 5 pump at the time of the event. On (b)(6) 2026, the patient experienced CGM inaccurate readings and the reporter and the patient attempted to manage the situation at home for approximately one day. The spouse was unable to recall the exact CGM values but estimated a difference of approximately 20 to 30 mg/dL between the CGM readings and fingerstick blood glucose (FSBG) measurements. The reporter could not recall whether the CGM values were higher or lower than the FSBG values. The only glucose value recalled was an FSBG reading of approximately 400 mg/dL. During this period, the patient experienced symptoms consistent with hyperglycemia, including irritability, difficulty expressing himself, and speech that was difficult to understand. On (b)(6) 2026, due to ongoing concerns, the reporter transported the patient to the Emergency Department (ED). Upon arrival, the CGM continued to display inaccurate readings; however, the spouse was unable to recall the specific CGM values. She only

  Patient problems: Altered State of Consciousness; Cognitive Changes; Confusion/ Disorientation; Hyperglycemia; Irritability

  MAUDE report 50675600 ↗
• MalfunctionSep 2, 2026Unable to Obtain Readings

  I had two (2) Dexcom G7 Glucose Sensor fail in a row and could not get a blood glucose reading to deliver my insulin. Both sensors are from the same lot. I am tired of having sensor after sensor fail, Dexcom product quality is dangerously poor. Dexcom put my life in danger when shipping faulty product. This is not a first time failure, on average one out of every four sensors has failed for me. The fact that the company replaces them is not a sufficient remedy. / UDI: (b)(4). (Dexcom G7 GSS (161) Integrated Continuous Glucose Monitoring System, Factory Calibrated). THIS REPORTS CAPTURES DEXCOM G7 #2. ANNEX A: 1516. ANNEX E: 4582. ANNEX G: 510. ANNEX F: 2199. REFERENCE REPORT MW6001784.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567905 ↗
• MalfunctionSep 2, 2026Unable to Obtain Readings

  I had two (2) Dexcom G7 Glucose Sensor fail in a row and could not get a blood glucose reading to deliver my insulin. Both sensors are from the same lot. I am tired of having sensor after sensor fail, Dexcom product quality is dangerously poor. Dexcom put my life in danger when shipping faulty product. This is not a first time failure, on average one out of every four sensors has failed for me. The fact that the company replaces them is not a sufficient remedy. / UDI: (b)(4) (Dexcom G7 GSS (161) Integrated Continuous Glucose Monitoring System, Factory Calibrated). THIS REPORTS CAPTURES DEXCOM G7 #1. ANNEX A: 1516. ANNEX E: 4582. ANNEX G: 510. ANNEX F: 2199. REFERENCE REPORT MW6001786.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567865 ↗
• MalfunctionSep 1, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550534 ↗
• MalfunctionAug 31, 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 50531790 ↗
• MalfunctionAug 27, 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 50487821 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that a detached needle or cannula occurred. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484623 ↗
• MalfunctionAug 24, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50413049 ↗
• MalfunctionAug 18, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301619 ↗
• MalfunctionJul 30, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092181 ↗
• MalfunctionJul 29, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065222 ↗
• MalfunctionJul 16, 2026Low Readings

  Patient problems: Hyperglycemia

  MAUDE report 25849408 ↗
• MalfunctionJul 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847718 ↗