CONTOUR® NEXT 7315Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10301937315012), received between Dec 17, 2019 and Aug 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K121190, K151742, K160430, K160682, K162336, K191286, K193407, K210687, K223293, 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. 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 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 79 MG/DL AT 5:15 A.M. AND 72 MG/DL AT 5:17 A.M. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. 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 22796328 ↗
• MalfunctionMay 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO PERFORM A CONTROL TEST WITH THE CONTOUR® NEXT ONE METER. WITH THE ASSISTANCE OF THE CUSTOMER SERVICE AGENT, THE CUSTOMER RAN A CONTROL TEST AND OBTAINED A READING OF 71 MG/DL AT 1:51 P.M. THE METER DID NOT AUTOMATICALLY MARK THE CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. 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 22106372 ↗
• MalfunctionDec 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO REPORT ABOUT AN ISSUE OF CONTROL READINGS BEING MARKED AS BLOOD TESTS IN THE MEMORY OF THE CONTOUR NEXT LINK METER. DURING TROUBLESHOOTING, CUSTOMER RAN CONTROL TESTS AND OBTAINED READINGS OF 48 MG/DL, 55 MG/DL AND 62 MG/DL. THE METER DID NOT AUTOMATICALLY MARK THE READING OF 48 MG/DL AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE CONTROL SOLUTION FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481740 ↗
• MalfunctionDec 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED CONTROL TESTS USING THE CONTOUR NEXT LINK METER AND OBTAINED READINGS OF 134 MG/DL AND 88 MG/DL. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE CONTROL SOLUTION FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121190, K151742, K160430, K160682, K162336, K191286, K193407, K210687, K223293, 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
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