CONTOUR® NEXT ONE 7818Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00301937818011), received between Jan 8, 2018 and Jul 15, 2025 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (26 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 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. 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 22509349 ↗
• MalfunctionJun 20, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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 19574273 ↗
• MalfunctionMay 20, 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 19351322 ↗
• MalfunctionJun 9, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT HE WAS UNABLE TO REPLACE THE BATTERIES ON THE CONTOUR NEXT ONE METER, AS HE WAS HAVING DIFFICULTY SLIDING THE BACK COVER OF THE METER TO REPLACE THE BATTERIES. AS THE METER WAS DEAD AND THE BATTERIES COULD NOT BE CHANGED, THE CUSTOMER WAS UNABLE TO PERFORM BLOOD GLUCOSE TESTING. THE CUSTOMER'S BLOOD SUGAR LEVEL WAS HIGH AND HE WAS HOSPITALIZED DUE TO STOMACH PARESIS AND WAS CONSTANTLY VOMITING AND HAD STOMACH PAIN. NO FURTHER EVENT DETAILS WERE PROVIDED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: Abdominal Pain; Hyperglycemia; Vomiting

  MAUDE report 17097302 ↗
• MalfunctionMay 2, 2023Missing 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 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 16853146 ↗
• MalfunctionFeb 1, 2023Missing 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 16277234 ↗
• MalfunctionJul 1, 2022Missing 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 14885300 ↗
• MalfunctionFeb 8, 2022Missing 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 13480290 ↗
• MalfunctionNov 16, 2021Missing 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 12819502 ↗
• MalfunctionSep 22, 2021Missing 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 12512727 ↗
• MalfunctionJun 15, 2021Missing 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. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998303 ↗
• MalfunctionMar 18, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515335 ↗
• MalfunctionNov 17, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT THE READINGS ON HIS CONTOUR NEXT ONE METER WERE 20 MG/DL TO 30 MG/DL HIGHER COMPARED TO THAT OBTAINED ON THE ALTERNATE METERS. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCONTINUED THE CALL, THEREFORE, THE DEVICE COULD NOT BE REQUESTED FOR EVALUATION AND THE REPLACEMENT DEVICE COULD NOT BE SENT. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10853993 ↗
• MalfunctionNov 12, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT ONE OF THEIR BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER WHICH WAS PROPERLY STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10830094 ↗
• MalfunctionJul 2, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT DURING THE WEEK SHE OBTAINED BLOOD GLUCOSE READING OF 260 MG/DL ON THE CONTOUR NEXT ONE METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS SHAKINESS AND WEAKNESS. THE CUSTOMER PERFORMED ANOTHER TESTING WITH THE NEIGHBOR'S METER AND OBTAINED A READING OF 60 MG/DL. THE CUSTOMER ATE CANDY AND RECOVERED WELL. 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. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Shaking/Tremors; Weakness

  MAUDE report 10225040 ↗
• MalfunctionJun 2, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10108241 ↗
• MalfunctionApr 9, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER STATED THAT HE PERFORMED A BLOOD GLUCOSE TEST ON THE CONTOUR NEXT ONE METER ON (B)(6) 2020 AND OBTAINED A READING OF 85 MG/DL AT 6:00 A.M. THE TIME SET ON THE METER WAS INCORRECT. DURING THE CALL, THE CUSTOMER CORRECTED THE TIME ON THE METER, HOWEVER, THE LAST READING PROVIDED BY THE CUSTOMER FROM THE METER MEMORY WAS THE READING OBTAINED ON (B)(6) 2020 AT 6:04 P.M., WHICH WAS 85 MG/DL. THE CUSTOMER STATED THAT THE READING FROM (B)(6) 2020 WAS NOT BEING STORED IN THE MEMORY OF THE 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 Known Impact Or Consequence To Patient

  MAUDE report 9943721 ↗
• MalfunctionMar 26, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884198 ↗
• MalfunctionJan 13, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS 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 METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581879 ↗
• MalfunctionDec 20, 2019Missing Test Results; Missing Test Results

  AN ADVOCATE REPORTED THAT THE CUSTOMER'S 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 METER IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503573 ↗
• MalfunctionDec 18, 2019Display Difficult to Read; Display Difficult to Read

  THE CUSTOMER REPORTED THAT THE CONTOUR NEXT ONE METER HAD WHITE SPOTS ON THE DISPLAY SCREEN. DURING IN-HOUSE INVESTIGATION, IT WAS DETERMINED THAT THE STRINGS OF WHITE SPOTS WERE OVER THE BLOOD GLUCOSE READINGS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER THE EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489947 ↗
• MalfunctionDec 3, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF 234 MG/DL ON THE CONTOUR NEXT ONE METER. HE PERFORMED REPEAT TESTING WITHIN 10 MINUTES USING TWO OTHER (NON-ASCENSIA) METERS AND OBTAINED READINGS OF AROUND 100 MG/DL. THE CUSTOMER TOOK AN EXTRA PILL OF METFORMIN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9404782 ↗
• MalfunctionNov 26, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT SINCE (B)(6) 2019 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 METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376816 ↗
• MalfunctionNov 21, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT WITHIN ONE MINUTE, SHE OBTAINED BLOOD GLUCOSE READINGS OF 262 MG/DL AND 128 MG/DL ON THE CONTOUR NEXT ONE METER AND NON-ASCENSIA METER RESPECTIVELY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCARDED THE TEST STRIPS. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353950 ↗
• MalfunctionJun 5, 2019Missing Test Results; Missing Test Results

  THE ADVOCATE REPORTED THAT THE CUSTOMER'S 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 ADVOCATE WAS ADVISED TO RETURN THE METER FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE ADVOCATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8671182 ↗