CONTOUR® 7109BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10301937109017), received between Oct 12, 2018 and Jul 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K062058, K090628); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN CONTROL TESTS ON HER CONTOUR METER AND OBTAINED READINGS OF 144 MG/DL, 40 MG/DL, 214 MG/DL AND 216 MG/DL. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS A 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 AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8747704 ↗
• MalfunctionOct 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN A CONTROL TEST ON A CONTOUR METER AND OBTAINED A RESULT OF 157 MG/DL. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. DURING THE CALL, THE CUSTOMER RAN ANOTHER CONTROL TEST AND THE RESULT OBTAINED WAS 118 MG/DL AND WAS MARKED AS CONTROL TEST. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE CONTROL SOLUTION FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960198 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062058, K090628. One submission often covers many models, so check the product and lot details in each record.

• Z-3268-2011 · Aug 12, 2011 · Terminated
  Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in w
• Z-1001-2007 · Jun 6, 2007 · Terminated
  Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.