C6 Sensor 02-01606Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B146C6D10), received between Jan 20, 2021 and Feb 23, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Data Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Difficult to Remove

  IT WAS REPORTED THAT THE MCOT SENSOR - 2.5 GOT STUCK IN THE CHARGER. TROUBLESHOOTING WAS PERFORMED HOWEVER, THE PATIENT WAS STILL UNABLE TO REMOVE THE SENSOR FROM THE CHARGER. THE PATIENT CONFIRMED THAT THEY DID REMOVE THE SENSOR FROM THE UNIVERSAL PATCH BEFORE PLACING THE SENSOR INTO THE CHARGER AND THAT THE SENSOR WAS NOT EXPOSED TO MOISTURE PRIOR TO THE EVENT. A REPLACEMENT WAS ORDERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415005 ↗
• InjuryMar 4, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED ON 10 FEBRUARY 2024, THAT ON (B)(6) 2024 THE PATIENT WENT TO THE EMERGENCY ROOM (ER) BECAUSE THEY FELT ELECTRIC SHOCKS UNDER THEIR ARMPIT AND TOWARDS THE LEFT SIDE OF THEIR CHEST. THE PATIENT STATED IT FELT LIKE A TEASER SHOCK. THE ER RAN TESTS SUCH AS AN EKG (ELECTROCARDIOGRAPHY) AND LAB WORK. EVERYTHING WAS NORMAL. THE HOSPITAL STAFF NOTED THAT IT COULD HAVE BEEN THE HEART MONITOR THAT COULD HAVE CAUSED THE ISSUE. THE PATIENT REMOVED THE DEVICE AND HAS NOT HAD ANY ISSUES SINCE REMOVING THE DEVICE.

  Patient problems: Electric Shock; Pain

  MAUDE report 18832869 ↗
• MalfunctionJan 23, 2024Overheating of Device; Data Problem; Overheating of Device; Data Problem

  IT PATIENT REPORTED THAT THEY CHARGED THE SNESOR AND THE PURPLE LIGHT CAME ON THE SENSOR. THE PATIENT TOOK THE SENSOR OFF THE CHARGER AND REPORTED THAT THE SENSOR WAS HOT AND HAD BURN MARKS ON THE SENSOR. THE PATIENT WAS CONCERNED THAT DATA WAS NOT BEING SENT AND THAT THE SENSOR WAS NOT WORKING. THE PATIENT SERVICES REP CONFIRMED THAT (B)(6) 2023 WAS THE LAST DAY DATA WAS RECEIVED. THE PATIENT WAS ADVISED TO RETURN THE DEVICE. A REPLACEMENT KIT WAS ORDERED AND THEIR SERVICE WAS EXTENDED. NO PATIENT HARM WAS REPOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566937 ↗
• MalfunctionJan 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  INSULIN DEPENDENT PATIENT COMMUNICATED READING DISCREPANCY BETWEEN DEXCOM CGM AND BIOTEL CARE BLOOD GLUCOSE METER. THE PATIENT INDICATED THAT THE DEXCOM CGM PRODUCED A READING OF 80 ML/DL, WHILE THE BIOTEL CARE BLOOD GLUCOSE METER PRODUCED A READING OF 200 MG/DL. TELCARE CUSTOMER SERVICE ATTEMPTED TO PERFORM CONTROL SOLUTION TESTING ON THE PHONE WITH THE PATIENT, BUT THE PATIENT'S CONTROL SOLUTION WAS EXPIRED. TELCARE CUSTOMER SERVICE OVERNIGHTED THE PATIENT CONTROL SOLUTION AND PROCEEDED TO PERFORM A TROUBLESHOOTING CALL. CONTROL SOLUTION TEST RESULTS (L1 AND L2) WERE BOTH IN RANGE. THERE IS NO KNOWN CONSEQUENCE TO THE PATIENT AND NO SERIOUS INJURY WAS REPORTED. PATIENT HAD NO FURTHER QUESTIONS OR CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205530 ↗