CONTOUR® NEXT ONE 7828Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00301937828010), received between Jan 2, 2024 and Aug 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Battery Problem; Battery Problem

  THE CUSTOMER CALLED TO REPORT THAT THE BATTERY OF THEIR CONTOUR® NEXT ONE METER EXPLODED. SHE MENTIONED OBSERVING ACID FROM THE 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 22827547 ↗
• MalfunctionNov 15, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CONTACTED 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. 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 20694451 ↗
• MalfunctionOct 2, 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 DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350823 ↗
• MalfunctionJan 2, 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 18425921 ↗