Dexcom G6 Sensor Kit (1) Medicare STS-OM-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,371 adverse event reports that list this exact device (DI 80386270000251), received between Jul 22, 2022 and Feb 6, 2026 — classified as 155 injuries, 2,216 malfunctions.

The most frequently reported specific device problem is “Imprecision” (879 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,371 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 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 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 24284984 ↗
• MalfunctionFeb 3, 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. 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 24251973 ↗
• MalfunctionDec 18, 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 AN OFF-LABEL INSERTION SITE, ON (B)(6) 2025. 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 23843697 ↗
• MalfunctionDec 4, 2025Low Readings; Low 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) 2025. 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 23712458 ↗
• MalfunctionDec 3, 2025Low Readings; Low 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) 2025. NO 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 23708575 ↗
• MalfunctionNov 20, 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 AN OFF-LABEL INSERTION SITE, ON (B)(6) 2025. 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 23606755 ↗
• MalfunctionNov 14, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT "EARLY SENSOR EXPIRATION" OCCURRED. THE SENSOR WAS INSERTED INTO AN OFF-LABEL INSERTION SITE, ON (B)(6) 2025 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 23560769 ↗
• MalfunctionNov 14, 2025Low Readings; Low 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, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. 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 23556298 ↗
• InjuryNov 12, 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 ABDOMEN ON (B)(6) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT INSERTED A NEW SENSOR. LATER THAT DAY, THE PATIENT¿S CGM WAS READING 400 MG/DL. THE PATIENT SELF-TREATED WITH AN INSULIN INJECTION. DESPITE THIS, THE PATIENT¿S CGM VALUE REMAINED AT 400 MG/DL. THE PATIENT THEN DECIDED TO TEST HIS BG METER READING WHICH WAS BETWEEN 155-160 MG/DL. AFTER A FEW MINUTES, THE PATIENT TESTED HIS BG METER READING AGAIN AND IT WAS 190 MG/DL WHILE THE CGM WAS READING 400 MG/DL. THE PATIENT ATTEMPTED TO CALIBRATE HIS DEXCOM DEVICE BUT THE CALIBRATION DID NOT BRING THE READING INTO AN EXPECTED RANGE. THE PATIENT¿S CGM THEN RAPIDLY STARTED CHANGING FROM 400 MG/DL TO 90 MG/DL WITHIN 5 MINUTES AND VICE VERSA. THE PATIENT THEN DECIDED TO GO TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT STARTED TO FEEL WEAK AND UNEASY. THE PATIENT¿S BG METER READING WAS 350 MG/DL WHILE THE CGM WAS READING 116 MG/DL. THE PATIENT¿S BLOOD PRESSURE WAS ALSO LOW. THE PATIENT HAD AN MRI AND CT SCAN DONE. HE WAS ADMITTED TO THE ICU FOR 2.5 DAYS AND THEN TRAN

  Patient problems: Hyperglycemia; Muscle Weakness/Atrophy

  MAUDE report 23534610 ↗
• InjuryNov 10, 2025Low Readings; Low 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) 2025. ON 10/27/2025, IT WAS REPORTED THAT THE PATIENT WAS AWAKENED BY AN ALARM ON HER CGM INDICATING AN URGENT LOW GLUCOSE ALERT WITHOUT A SPECIFIC VALUE. SHE FELT DIZZY AND, WITHOUT CHECKING HER BLOOD GLUCOSE VIA FINGERSTICK , SHE DRANK ORANGE JUICE BEFORE RETURNING TO SLEEP. LATER, SHE WAS AGAIN AWAKENED BY ANOTHER URGENT LOW ALARM AND CONSUMED MORE ORANGE JUICE. DESPITE THIS, SHE CONTINUED TO EXPERIENCE FREQUENT URINATION AND NOTICED THAT HER CGM STILL DISPLAYED AN URGENT LOW ALERT. SHE THEN CHECKED HER BLOOD GLUCOSE WITH A FINGERSTICK, WHICH READ 587 MG/DL, WHILE THE CGM CONTINUED TO SHOW URGENT LOW WITH NO NUMERIC VALUE. THE PATIENT REMOVED HER CGM SENSOR, ADMINISTERED 10 UNITS OF HUMALOG BY INJECTION, AND WAS TRANSPORTED TO THE HOSPITAL BY HER SISTER. AT THE EMERGENCY ROOM (ER), HER BLOOD GLUCOSE WAS 562 MG/DL. SHE WAS TREATED WITH INSULIN DRIP AND RECEIVED IV FLUIDS WITH MAGNESIUM, POTASSIUM, SODIUM, AND SALINE. SHE REMAINED HOSPITALIZED OVERNIGHT. AT THE TIME OF DISCHARGE, HER BLOOD GLUCOSE WAS 91 MG/DL

  Patient problems: Dizziness; Hyperglycemia; Urinary Frequency / Polyuria

  MAUDE report 23513930 ↗
• MalfunctionNov 10, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED FREQUENTLY BETWEEN (B)(6) 2025. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. 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 FREQUENTLY 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 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 23510330 ↗
• MalfunctionNov 10, 2025Low Readings; Low 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. 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 23509916 ↗
• MalfunctionNov 6, 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 ABDOMEN ON (B)(6) 2025. 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hypoglycemia

  MAUDE report 23490910 ↗
• MalfunctionNov 6, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. PERFORMANCE DATA WAS REVIEWED. A SENSOR FAILURE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, AN EARLY SENSOR EXPIRATION WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE EARLY SENSOR EXPIRATION COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486902 ↗
• MalfunctionNov 6, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN. PERFORMANCE DATA WAS REVIEWED. A SENSOR FAILURE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, AN EARLY SENSOR EXPIRATION WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE EARLY SENSOR EXPIRATION WAS DETERMINED TO BE TRANSMITTER STALE STOP COMMAND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486886 ↗
• MalfunctionNov 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT "EARLY SENSOR EXPIRATION" 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 23481969 ↗
• MalfunctionNov 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT "EARLY SENSOR EXPIRATION" 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 23480697 ↗
• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. THE SENSOR POD WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO MISSING SENSOR WIRE. APPLICATOR DEPLOYMENT WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, DETACHED OR MISSING SENSOR WIRE WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE DETACHED OR MISSING SENSOR WIRE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477039 ↗
• MalfunctionNov 4, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT "EARLY SENSOR EXPIRATION" 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 23469841 ↗
• MalfunctionNov 4, 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 THIGH, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hypoglycemia

  MAUDE report 23469149 ↗
• MalfunctionNov 3, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. 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 C ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 23455569 ↗
• MalfunctionNov 3, 2025Low Readings; Low 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 UPPER BUTTOCKS ON (B)(6) 2025. 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 23455489 ↗
• MalfunctionNov 3, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT START NEW SENSOR OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS AN EARLY SENSOR EXPIRATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE EARLY SENSOR EXPIRATION. THE PROBABLE CAUSE OF THE EARLY SENSOR EXPIRATION COULD NOT BE DETERMINED. THE REPORTED EVENT OF A START NEW SENSOR IS REPORTABLE BASED ON THE FINDING OF AN EARLY SENSOR EXPIRATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444564 ↗
• MalfunctionOct 30, 2025Low Readings; Low 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) 2025. 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 B ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 23430945 ↗
• MalfunctionOct 29, 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 ABDOMEN ON (B)(6) 2025. 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 C ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418041 ↗