CONTOUR® NEXT ONE 7824Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00301937824012), received between Dec 10, 2019 and Dec 11, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (9 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.

• MalfunctionDec 11, 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. THE CUSTOMER STATED THAT HE HAD CHANGED THE METER'S BATTERIES. THE CUSTOMER COULD NOT PROVIDE THE DATE THE BATTERIES WERE CHANGED. 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 20903587 ↗
• MalfunctionDec 11, 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. THE CUSTOMER STATED THAT HE HAD CHANGED THE METER'S BATTERIES. THE CUSTOMER COULD NOT PROVIDE THE DATE THE BATTERIES WERE CHANGED. 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 20903529 ↗
• 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 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 17470417 ↗
• MalfunctionJan 23, 2023Nonstandard Device; Nonstandard Device

  A CUSTOMER FROM AUSTRALIA REPORTED THAT HIS CONTOUR NEXT ONE METER WAS READING IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224576 ↗
• MalfunctionSep 29, 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502311 ↗
• MalfunctionMar 24, 2022Missing Test Results; Missing Test Results

  A NURSE CONTACTED ON BEHALF OF THE CUSTOMER TO REPORT 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 DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892268 ↗
• MalfunctionOct 18, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED THE ASCENSIA CUSTOMER CARE TO SEEK HELP WITH THE CONTOUR NEXT ONE METER. DURING TROUBLESHOOTING, TWO BLOOD GLUCOSE TESTS WERE PERFORMED WITH THE METER AND ONE OF THE READINGS OBTAINED DURING TROUBLESHOOTING WAS NOT STORED IN 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 12647299 ↗
• MalfunctionSep 13, 2021Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message; Device Markings/Labelling Problem

  ASCENSIA DIABETES CARE CONTROL SOLUTION PRODUCT 7109B, NDC# 0193-7109-01 IS INCORRECTLY LABELED AND VERY POORLY DOCUMENTED, RESULTING IN MY INABILITY TO USE THE PURCHASED PRODUCT. IT STATES THAT IT IS: FOR USE WITH ALL CONTOUR BLOOD GLUCOSE MONITORING SYSTEMS. I HAVE THE CONTOUR NEXT ONE METER. AFTER 3 EMAILS AND 3 CALLS TO THEIR SUPPORT LINE, THE REP SAID THAT I NEEDED A DIFFERENT CONTROL SOLUTION, BECAUSE IT PRODUCES AN ERROR ON THE METER. I SEARCHED THE INCLUDED DOCUMENTATION AND ON THE PRODUCT SITE TO FIND WHAT SOLUTION SHOULD BE USED, BUT IT WAS NOT LISTED. ADDITIONALLY, THE METER KIT SHOWS THAT IT INCLUDES 20 TEST STRIPS BUT IT ONLY CONTAINS ONE BOX OF 10. THE KIT IS NDC# 0193-7824-01. ON MY FIRST 2 CALLS TO THEIR SUPPORT LINE, NEITHER OF THE REPS HAD A CLUE ABOUT WHAT I WAS SAYING. THE ENGLISH WAS FINE, BUT THEY WERE UNABLE TO COMPREHEND THE ISSUE WHATSOEVER. THAT INDICATES POOR TRAINING, POOR QUALITY CONTROL AND THAT CUSTOMER SERVICE IS NOT COMPETENT IN RESOLVING PROBLEMS. BECAUSE OF PROBLEMS WITH THE METER WHICH PROMPTED ME TO USE THE CONTROL SOLUTION, I AM FORCED TO TRASH THE PURCHASED CONTROL SOLUTION AND LIKELY DISCARD THE METER KIT, AND 70 ADDITIONAL TEST STRIPS BECAUS

  Patient problems: Insufficient Information

  MAUDE report 12467106 ↗
• MalfunctionMay 8, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT HER BLOOD GLUCOSE READING WAS 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 Known Impact Or Consequence To Patient

  MAUDE report 10038340 ↗
• MalfunctionApr 20, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS 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 9977161 ↗
• MalfunctionDec 10, 2019Missing 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 Known Impact Or Consequence To Patient

  MAUDE report 9444746 ↗