CONTOUR® NEXT GEN 7383Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00301937383014), received between Nov 15, 2024 and Sep 10, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K193407, K241787); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Missing 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. THE CUSTOMER STATED THAT SHE HAD CHANGED THE DATE AND TIME SETTINGS ON THE 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 23016614 ↗
• MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A DISCREPANCY IN THE SERVICE MODE OF THE CONTOUR® NEXT GEN METER, WHICH DISPLAYED 97 READINGS, DESPITE THE CUSTOMER HAVING CONDUCTED ONLY 73 BLOOD GLUCOSE TESTS TILL (B)(6) 2025. 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 22583506 ↗
• MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 495 MG/DL AND 78 MG/DL WITH THE CONTOUR® NEXT GEN METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER DECLINED TO RECEIVE THE REPLACEMENT METER. 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 22205702 ↗
• MalfunctionDec 3, 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 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 20834030 ↗
• MalfunctionDec 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 385 MG/DL AND 88 MG/DL WITH 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. 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 20833987 ↗
• MalfunctionNov 15, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER FROM WALMART, WHICH CAME WITH A 90-DAY AVERAGE READING OF 87 MG/DL, EVEN THOUGH SHE HAD NOT PERFORMED ANY BLOOD GLUCOSE TEST WITH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20694452 ↗
• MalfunctionNov 15, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT SHE PURCHASED A CONTOUR NEXT GEN METER FROM WALMART, WHICH CAME WITH BLOOD GLUCOSE READINGS IN THE METER'S MEMORY, EVEN THOUGH SHE HAD NOT PERFORMED ANY BLOOD GLUCOSE TEST WITH THE METER AT THAT TIME. LATER, THE READINGS WHICH CAME UPON PURCHASE OF THE METER WERE NOT STORED IN THE METER'S MEMORY. THE CUSTOMER HAD RESET THE TIME AND DATE ON THE METER ON (B)(6) 2024. SINCE PURCHASING THE METER, THE CUSTOMER HAD PERFORMED FIVE BLOOD TESTS WITH THE METER AND ALL FIVE READINGS WERE PROPERLY 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 20694449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193407, K241787. One submission often covers many models, so check the product and lot details in each record.

• Z-2211-2023 · May 19, 2023 · Open, Classified
  Contour next GEN Blood Glucose Monitoring System