CONTOUR® 7189Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00301937189012), received between Sep 20, 2019 and Jan 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K062058); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2024Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT HE PURCHASED A CONTOUR METER FROM CANADA AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. 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 18475578 ↗
• MalfunctionMar 24, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR 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 11566522 ↗
• MalfunctionAug 24, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED TO REPORT THAT ONE OF THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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 10443038 ↗
• MalfunctionMay 8, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT SOME OF HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR 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 10038342 ↗
• MalfunctionFeb 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 392 MG/DL AND 60 MG/DL AT 11:36 A.M. AND 11:42 A.M. RESPECTIVELY WHEN USING THE CONTOUR METER. AT 12:11 P.M., ANOTHER TESTING WAS PERFORMED AND A READING OF 23 MG/DL WAS OBTAINED. THE CUSTOMER WAS PRESENTING SYMPTOMS SUCH AS HEADACHE AND NAUSEA. BASED ON THE READING OF 23 MG/DL AND CUSTOMER'S SYMPTOMS, THE SCHOOL NURSE GAVE JUICE TO THE CUSTOMER. THE CUSTOMER ALSO ATE PEANUT BUTTER. HOWEVER, THE SYMPTOMS PERSISTED. THE SCHOOL NURSE PERFORMED A TEST WITH HER METER AND OBTAINED A READING OF 590 MG/DL. NO FURTHER EVENT DETAILS WERE PROVIDED. 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. THE CUSTOMER STATED THAT THE PRODUCT DETAILS FROM THE BOTTLE OF TEST STRIPS WERE WORN OFF AND THEREFORE, WAS UNABLE TO PROVIDE THE INFORMATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Headache; Nausea

  MAUDE report 9756847 ↗
• MalfunctionSep 20, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097985 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062058. 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---.