Dexcom G7 GSS (161) 9500-161Recalls & reported problems

Summary

The FDA's MAUDE database contains 70,146 adverse event reports that list this exact device (DI 00386270003935), received between Jan 22, 2024 and May 21, 2026 — classified as 1,006 injuries, 69,140 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27,424 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 70,146 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247586 ↗
• MalfunctionApr 13, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866705 ↗
• MalfunctionApr 9, 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 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 24834905 ↗
• MalfunctionApr 8, 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 24821517 ↗
• MalfunctionMar 30, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730788 ↗
• MalfunctionMar 26, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708042 ↗
• MalfunctionMar 26, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701042 ↗
• MalfunctionMar 25, 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 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 24690210 ↗
• MalfunctionMar 24, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676700 ↗
• InjuryMar 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  I AM A DIABETIC AND HAVE USED A DEXCOM G7 GLUCOSE SENSOR FOR JUST UNDER TWO YEARS. I HAVE ALWAYS USED THE 10-DAY SENSOR AND I WEAR THEM CONTINUOUSLY. PREVIOUSLY, MY DIABETES WAS TREATED WITH SHORT- AND LONG-ACTING INSULIN AND METFORMIN. IN (B)(6) 2025, I STOPPED INSULIN THERAPY AND IT WAS REPLACED WITH MOUNJARO. ON (B)(6) 2026 MY DEXCOM G7 SENSOR FAILED. THIS FAILURE FOLLOWED THE FAILURE OF THREE CONSECUTIVE SENSORS I USED PRIOR TO THE CURRENT ONE. IN ALL FOUR CASES, THE SENSORS BEGAN REPORTING WILDLY INACCURATE READINGS. IN SOME CASES, THE READINGS WERE SIGNIFICANTLY LOWER THAN THOSE CONFIRMED BY A FINGER STICK BLOOD SAMPLE OR SIGNIFICANTLY HIGHER THAN THOSE CONFIRMED BY A FINGER STICK. FOR EXAMPLE, I RECEIVED AN ALERT THIS MORNING (THE DAY OF THIS REPORT) FROM MY MOBILE DEVICE THAT MY BLOOD GLUCOSE WAS 40 MG/DL. I IMMEDIATELY TESTED MY BLOOD SUGAR WITH MY GLUCOSE TEST METER. I PERFORMED THREE FINGER STICKS AND THE READINGS WERE 120, 115, AND 125. I PROCEEDED TO CALIBRATE THE G7 USING THE DEXCOM APP ON MY MOBILE DEVICE. THE READINGS FROM THE G7 SUBSEQUENTLY WERE ACCURATE WITHIN 10% OF THOSE OBTAINED BY FINGER STICK. HOWEVER, WITHIN 45 MINUTES OF THE CALIBRATION I RECEIVED A SECOND

  Patient problems: Blurred Vision; Hyperglycemia; Hypoglycemia

  MAUDE report 24674516 ↗
• MalfunctionMar 23, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671004 ↗
• MalfunctionMar 18, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634416 ↗
• MalfunctionMar 18, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629966 ↗
• MalfunctionMar 10, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563502 ↗
• MalfunctionMar 10, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560951 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE WEARABLE WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO BROKEN SENSOR WIRE. THE APPLICATOR WAS ALSO PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545236 ↗
• MalfunctionMar 6, 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 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 24533220 ↗
• MalfunctionMar 6, 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 DETACHED 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 24531467 ↗
• MalfunctionMar 5, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514868 ↗
• MalfunctionMar 4, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512722 ↗
• MalfunctionMar 4, 2026Break

  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 FAILED. AN APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A BROKEN SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE BROKEN SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506431 ↗
• MalfunctionFeb 27, 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 24477128 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT APPLICATOR DEPLOYMENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE WEARABLE WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FOUND NO DAMAGE. THE APPLICATOR WAS ALSO PROVIDED FOR INVESTIGATION. THE EXTERNAL VISUAL INSPECTION WAS PERFORMED, AND NO DAMAGE WAS FOUND. THE INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE DETACHED NEEDLE. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, BROKEN OR DETACHED NEEDLE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. 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 24463990 ↗
• MalfunctionFeb 26, 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 24461181 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN 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 BROKEN 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 24455407 ↗