Skip to content

Dexcom G7 Sample Pack (161) STE-AT-030Recalls & reported problems

Dexcom, Inc. · G7, Sample 1-Pack Sensor Unit, US · Class 2

Quick summary

This Dexcom G7 glucose sensor has 1,447 FDA adverse event reports, with 44 injuries, 1,403 malfunctions and no deaths. The reports mostly describe signal loss between the sensor and the phone app, sensors coming loose, and glucose readings that run too low or too high. Reports rose over the last 12 months, to 1,028 from 407 in the 12 months before. No recalls name this device.

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
1,447
Deaths reported
0
Injuries reported
44
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,447 adverse event reports that list this exact device (DI 00386270004123), received between Feb 2, 2024 and Jul 27, 2026 — classified as 44 injuries, 1,403 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (804 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: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 4 reportsJun 2024: 5 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 3 reportsMay 2025: 156 reportsJun 2025: 32 reportsJul 2025: 15 reportsAug 2025: 5 reportsSep 2025: 55 reportsOct 2025: 134 reportsNov 2025: 174 reportsDec 2025: 212 reportsJan 2026: 175 reportsFeb 2026: 157 reportsMar 2026: 191 reportsApr 2026: 113 reportsMay 2026: 4 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports202420252026212
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Wireless Communication Problem804
  • Detachment of Device or Device Component247
  • Low Readings235
  • High Readings65
  • Break40
  • Incorrect, Inadequate or Imprecise Result or Readings27
  • Appropriate Device Problem Term/Code Not Available12
  • Premature End-of-Life Indicator8

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,120
  • Hyperglycemia244
  • Hypoglycemia45
  • Foreign Body In Patient18
  • Dizziness14
  • Nausea10
  • Vomiting10
  • Loss of consciousness9

Recent adverse event reports

The 25 most recent of 1,447 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 27, 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 50028447 ↗
  • MalfunctionJun 18, 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 WAS 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 25549187 ↗
  • MalfunctionMay 5, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25083753 ↗
  • MalfunctionMay 5, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN (B)(6) 2026. 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 ONE HOUR RARELY WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS 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 25082096 ↗
  • 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 25058792 ↗
  • 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 25058782 ↗
  • MalfunctionApr 30, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 25047563 ↗
  • MalfunctionApr 30, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN (B)(6) 2026 AND (B)(6) 2026. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WAS FOUND FREQUENTLY WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS 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 25038689 ↗
  • MalfunctionApr 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 25038587 ↗
  • MalfunctionApr 29, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 25037912 ↗
  • MalfunctionApr 29, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25032427 ↗
  • MalfunctionApr 28, 2026Wireless Communication Problem

    IT WAS REPORTED THAT "SIGNAL LOSS" OCCURRED. 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 25023593 ↗
  • MalfunctionApr 28, 2026Wireless Communication Problem

    IT WAS REPORTED THAT "SIGNAL LOSS" OCCURRED. 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 25011426 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25010317 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25010013 ↗
  • MalfunctionApr 27, 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. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Hyperglycemia

    MAUDE report 25009543 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25008574 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 25005762 ↗
  • MalfunctionApr 27, 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 25001203 ↗
  • MalfunctionApr 27, 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. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Hyperglycemia

    MAUDE report 25000983 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25000265 ↗
  • MalfunctionApr 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. 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 24987977 ↗
  • MalfunctionApr 24, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN (B)(6) 2026. 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 ONE HOUR FREQUENTLY 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 24984462 ↗
  • MalfunctionApr 24, 2026Wireless Communication Problem

    IT WAS REPORTED THAT A 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 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 24983971 ↗
  • MalfunctionApr 23, 2026Wireless Communication Problem

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24972326 ↗

Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices

All Integrated Continuous Glucose Monitoring System, Factory Calibrated devices →

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