CONTOUR® NEXT ONE 7825Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00301937825019), received between May 22, 2023 and Jan 6, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR® NEXT ONE METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980738 ↗
• MalfunctionDec 3, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR® NEXT ONE METER. THE CUSTOMER HAD RECENTLY REPLACED THE METER'S BATTERY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706077 ↗
• MalfunctionAug 27, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR® NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906712 ↗
• MalfunctionAug 20, 2025Nonstandard Device; Nonstandard Device

  THE CUSTOMER FROM UNITED KINGDOM REPORTED THAT SHE BOUGHT THE CONTOUR® NEXT ONE METER FROM AMAZON AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THE CUSTOMER NOTICED THE ISSUE DURING THE INITIAL USE OF DEVICE AND THEREFORE, NO BLOOD GLUCOSE TESTING WAS PERFORMED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852053 ↗
• MalfunctionJul 8, 2025Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT ONE METER. THE ADVOCATE STATED THAT THE BATTERIES WERE REMOVED FROM THE METER PRIOR TO THE EVENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437401 ↗
• MalfunctionMar 3, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR® NEXT ONE METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT STORED IN THE METER'S MEMORY. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA, HOWEVER, DID NOT RECEIVE ANY TREATMENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: Hyperglycemia

  MAUDE report 21504293 ↗
• MalfunctionDec 3, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833997 ↗
• MalfunctionOct 29, 2024Nonstandard Device; Nonstandard Device

  A CUSTOMER FROM UNITED KINGDOM (UK) REPORTED THAT THE CONTOUR NEXT ONE METER PURCHASED IN UK FROM AMAZON WEBSITE WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER RETURNED THE SUSPECTED DEVICE TO AMAZON. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559191 ↗
• MalfunctionJun 25, 2024Nonstandard Device; Nonstandard Device

  A CUSTOMER FROM UNITED KINGDOM (UK) REPORTED THAT THE CONTOUR NEXT ONE METER PURCHASED IN UK FROM AMAZON WEBSITE WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605524 ↗
• MalfunctionFeb 1, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622493 ↗
• MalfunctionMay 22, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973338 ↗