Dexcom G7 GSS (160) 9500-160Recalls & reported problems
Dexcom, Inc. · G7 GSS BLE Enhancement · Class 2
All models of Dexcom G7 (32) · Dexcom G7 GSS (160) (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Dexcom G7 sensor. Its reports mostly describe sensors detaching, signal loss, inaccurate readings and sensor failures the app did not alert on. There are 33,024 reports, with no deaths and 372 injuries. No recalls name this device. Reports dropped to 8 in the most recent 12 months on record, from 7,541 in the 12 months 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
- 33,025
- Deaths reported
- 0
- Injuries reported
- 372
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33,025 adverse event reports that list this exact device (DI 00386270003584), received between Oct 9, 2023 and Sep 15, 2026 — classified as 372 injuries, 32,653 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (16,573 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem16,573
- Detachment of Device or Device Component7,385
- Incorrect, Inadequate or Imprecise Result or Readings4,394
- Break1,775
- Premature End-of-Life Indicator1,534
- Appropriate Device Problem Term/Code Not Available992
- Display or Visual Feedback Problem149
- Unintended Application Program Shut Down142
Patient problems
- No Clinical Signs, Symptoms or Conditions29,002
- Hyperglycemia3,061
- Hypoglycemia610
- Foreign Body In Patient208
- Loss of consciousness96
- Dizziness90
- Erythema56
- Fatigue55
Recent adverse event reports
The 25 most recent of 33,025 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782193 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO MISSING NEEDLE. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN OR DETACHED NEEDLE OR CANNULA WAS FOUND IN CONNECTION TO THE REPORTED EVENT. THE PROBABLE CAUSE OF THE BROKEN OR DETACHED NEEDLE OR CANNULA COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506301 ↗MalfunctionFeb 18, 2026Protective Measures Problem
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. PRODUCT WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380206 ↗MalfunctionJan 12, 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 FAILED. 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 24045556 ↗MalfunctionJan 3, 2026Protective Measures Problem
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. DATA WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23953030 ↗MalfunctionDec 31, 2025Protective Measures Problem; Protective Measures Problem
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. DATA WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23938780 ↗MalfunctionDec 31, 2025Protective Measures Problem; Protective Measures Problem
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. DATA WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23938713 ↗MalfunctionDec 4, 2025Wireless Communication Problem; Wireless 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 FAILED. 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 23720093 ↗MalfunctionDec 4, 2025Wireless Communication Problem; Wireless 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 FAILED. 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 23718012 ↗MalfunctionSep 18, 2025Wireless Communication Problem; Wireless 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 FAILED. 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 23089054 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment 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) 2025. 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 23066042 ↗MalfunctionSep 16, 2025Wireless Communication Problem; Wireless 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 23062920 ↗MalfunctionSep 16, 2025High Readings; High 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) 2025. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED SENSOR, WHICH IS MISUSE OF THE DEVICE. 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: Hypoglycemia
MAUDE report 23062138 ↗MalfunctionSep 15, 2025Wireless Communication Problem; Wireless 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 23058073 ↗MalfunctionSep 12, 2025Wireless Communication Problem; Wireless Communication Problem
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 9/10/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042407 ↗MalfunctionSep 11, 2025Wireless Communication Problem; Wireless 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 23032649 ↗MalfunctionSep 10, 2025Wireless Communication Problem; Wireless 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 23018802 ↗MalfunctionSep 10, 2025Wireless Communication Problem; Wireless 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 23015666 ↗MalfunctionSep 9, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A NO READINGS/ SENSOR ERROR/ BRIEF SENSOR ISSUE OCCURRED. PERFORMANCE DATA WAS REVIEWED. NO READINGS/ SENSOR ERROR/ BRIEF SENSOR 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 23001540 ↗MalfunctionSep 8, 2025Wireless Communication Problem; Wireless 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 22997779 ↗MalfunctionSep 8, 2025Wireless Communication Problem; Wireless 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 22994059 ↗MalfunctionSep 5, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH WAS PERFORMED AND FAILED. 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 22986421 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22982521 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22981553 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22981528 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page