CONTOUR® NEXT GEN 7917Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00301937917011), received between May 22, 2023 and Sep 2, 2025 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (50 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. May 19, 2023Open, Classified

   Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.

   Z-2211-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THE CUSTOMER PROVIDED EXAMPLES OF BLOOD GLUCOSE READINGS FROM THE METER'S MEMORY AS 20.6 MMOL/L, 19.4 MMOL/L, 18.9 MMOL/L, 17.5 MMOL/L AND 10.7 MMOL/L. 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 22939428 ↗
• MalfunctionAug 21, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THE CUSTOMER PROVIDED AN EXAMPLE OF A BLOOD GLUCOSE READING FROM THE METER'S MEMORY AS 5.2 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED TO RETURN THE DEVICE. ALTHOUGH THE CUSTOMER WAS OFFERED A REPLACEMENT METER KIT, THE CUSTOMER REFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861741 ↗
• MalfunctionJul 8, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 22436762 ↗
• MalfunctionJan 2, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR® NEXT GEN METER IN THE US FROM AMAZON WEBSITE AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 21057259 ↗
• MalfunctionNov 21, 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 GEN 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 20746717 ↗
• MalfunctionOct 15, 2024Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453882 ↗
• MalfunctionOct 15, 2024Nonstandard Device; Nonstandard Device

  A CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453681 ↗
• MalfunctionSep 25, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR NEXT GEN METER. DURING 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 20301504 ↗
• MalfunctionSep 4, 2024Nonstandard Device; Nonstandard Device

  A HEALTH CARE PROFESSIONAL (HCP) CALLED TO REPORT THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE HCP WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135393 ↗
• MalfunctionJun 10, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 19499273 ↗
• MalfunctionApr 9, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 19073071 ↗
• MalfunctionMar 12, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 18883532 ↗
• MalfunctionMar 5, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 18834475 ↗
• MalfunctionNov 13, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 18119253 ↗
• MalfunctionNov 10, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 18111071 ↗
• MalfunctionSep 8, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17711967 ↗
• MalfunctionSep 1, 2023Nonstandard Device; Nonstandard Device

  THE ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17670653 ↗
• MalfunctionSep 1, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17669602 ↗
• MalfunctionAug 15, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17548373 ↗
• MalfunctionAug 7, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17470426 ↗
• MalfunctionAug 4, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17460189 ↗
• MalfunctionAug 4, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT HE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17460187 ↗
• MalfunctionAug 1, 2023Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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 17435144 ↗
• MalfunctionAug 1, 2023Nonstandard Device; Nonstandard Device

  A HEALTH CARE PROFESSIONAL (HCP) CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY PURCHASED A CONTOUR NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE HCP WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. THE HCP WAS ADVISED FOR THE CUSTOMER TO CALL US BACK TO GET THE REPLACEMENT METER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435143 ↗
• MalfunctionAug 1, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 39 MG/DL, 204 MG/DL AND 190 MG/DL WITHIN 1 MINUTE ON THE CONTOUR NEXT GEN METER. 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 17435142 ↗