CONTOUR® NEXT 7377Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00301937377013), received between Jan 8, 2018 and Dec 12, 2025 — classified as 7 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (78 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Missing Test Results; Missing Test Results

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791082 ↗
• MalfunctionJun 9, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT AFTER REPLACING THE BATTERY OF THE CONTOUR® NEXT METER, HIS BLOOD GLUCOSE READINGS WERE NOT BEING 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 22168986 ↗
• MalfunctionJun 3, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT AFTER REPLACING THE BATTERY OF THE CONTOUR® NEXT METER, HIS READINGS WERE NOT BEING 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 22133917 ↗
• MalfunctionApr 3, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING 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 21768124 ↗
• MalfunctionMar 13, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT 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 21596233 ↗
• MalfunctionSep 16, 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 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AS THE CUSTOMER THREW IT AWAY. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226712 ↗
• MalfunctionJul 1, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR NEXT METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT ONE OF THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS 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 19643432 ↗
• MalfunctionJun 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 METER. THE DATE AND TIME SET ON THE METER WERE INCORRECT. 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 19576319 ↗
• MalfunctionMar 25, 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 METER. THE DATE AND TIME SET ON THE METER WERE INCORRECT. 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 18967892 ↗
• MalfunctionJan 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN THREE BLOOD GLUCOSE TESTS WITH THE CONTOUR NEXT METER AND EACH READING WAS DIFFERENT BY OVER 100 MG/DL. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. 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 18536505 ↗
• MalfunctionSep 29, 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 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 17842531 ↗
• InjuryAug 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE TOOK MORE THAN USUAL INSULIN BASED ON THE BLOOD GLUCOSE RESULT OBTAINED ON THE CONTOUR NEXT METER AND HAD TO GO TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. 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: Insufficient Information

  MAUDE report 17548369 ↗
• MalfunctionAug 7, 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 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 17470432 ↗
• MalfunctionMay 15, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930876 ↗
• InjuryMay 15, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT SHE WAS UNABLE TO PERFORM BLOOD GLUCOSE TEST WITH THE CONTOUR NEXT METER AS THE METER WAS DEAD. SHE WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA WHICH WERE DESCRIBED AS BEING DIZZY AND THIRSTY. THE CUSTOMER WENT TO A PHYSICIAN'S OFFICE WHERE A BLOOD GLUCOSE TEST WAS PERFORMED AND A READING OF 175 MG/DL WAS OBTAINED. THE CUSTOMER WAS GIVEN AN INJECTION (UNKNOWN MEDICATION). AFTER, SHE WENT HOME AND RAN ANOTHER BLOOD GLUCOSE TEST AND OBTAINED A READING OF 139 MG/DL. THE CUSTOMER RECOVERED WELL AFTER THE TREATMENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 16930872 ↗
• MalfunctionMay 9, 2023Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF HER HUSBAND TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT METER AFTER SHE PLACED THE METER THROUGH AN X-RAY SCANNER IN THE AIRPORT. 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 16894591 ↗
• MalfunctionMay 9, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED TO REPORT THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT 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 16894590 ↗
• MalfunctionApr 18, 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 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 16761457 ↗
• MalfunctionMar 20, 2023Missing 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 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 16577188 ↗
• MalfunctionFeb 6, 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 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 16304668 ↗
• InjuryFeb 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE WAS OBTAINING INACCURATE READINGS WITH THE CONTOUR NEXT METER. THE CUSTOMER STATED THAT THE READINGS WERE NOT IN ALIGNMENT WITH HER SYMPTOMS. FOR EXAMPLE, IF THE METER GAVE HIGH READINGS, THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA, WHILE WHEN THE METER GAVE LOW READINGS, SHE WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER STATED THAT SHE SOUGHT MEDICAL ATTENTION. NO FURTHER DETAILS WERE PROVIDED. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION. THE METER IS NO EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 16304664 ↗
• 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 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 16277667 ↗
• MalfunctionJan 23, 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 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 16224583 ↗
• MalfunctionJan 11, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT 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 16137302 ↗
• MalfunctionNov 17, 2022High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER TOOK 16 UNITS OF INSULIN. THE CUSTOMER WAS FEELING WEAK AND ATE 2 BARS OF CHOCOLATE AND FELT SAME AFTERWARDS. THE CUSTOMER WENT TO THE PHYSICIAN'S OFFICE WHERE HE OBTAINED BLOOD GLUCOSE READINGS OF 83 MG/DL WITH THE CONTOUR NEXT METER AND 52 MG/DL WITH THE LABORATORY TESTING WITHIN 6 MINUTES. EVEN THOUGH, A LOW READING WAS OBTAINED WITH THE LABORATORY TESTING, THE PHYSICIAN ADVISED THE CUSTOMER TO INCREASE THE INSULIN DOSAGE BASED ON METER'S READINGS. 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. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15813191 ↗