CONTOUR® 7151HRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00301937151019), received between Dec 29, 2017 and Sep 10, 2024 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (28 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT AFTER THE CUSTOMER REPLACED THE METER'S BATTERY, THE BLOOD GLUCOSE READINGS WERE NOT BEING 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 20178249 ↗
• MalfunctionFeb 1, 2024Missing 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 18622491 ↗
• MalfunctionApr 3, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT 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 16663597 ↗
• MalfunctionMay 17, 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 11832093 ↗
• MalfunctionMay 11, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807828 ↗
• MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT HER BLOOD GLUCOSE READING WAS INCORRECTLY STORED IN THE MEMORY OF THE CONTOUR METER. THE CUSTOMER STATED THAT SHE OBTAINED A READING OF 189 MG/DL WHICH WAS STORED AS 195 MG/DL. 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 11493812 ↗
• MalfunctionJan 14, 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 11169308 ↗
• MalfunctionDec 4, 2020Nonstandard Device; Nonstandard Device

  THE CUSTOMER ALLEGED TO HAVE PURCHASED A CONTOUR METER IN US AND FOUND THAT THE METER WAS READING IN MMOL/L. 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 10949157 ↗
• MalfunctionNov 12, 2020High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY OBTAINED BLOOD GLUCOSE READINGS OF 218 MG/DL AT 10:39 A.M. ON A NON-ASCENSIA METER AND 473 MG/DL AT 10:49 A.M. ON 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. THE ADVOCATE STATED THAT THEY USED ALL THE TEST STRIPS, AND DISPOSED THE BOTTLE. 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 10830089 ↗
• MalfunctionNov 12, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEIR BLOOD GLUCOSE READINGS FROM (B)(6) 2020 WERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10830087 ↗
• MalfunctionOct 28, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED TO REPORT THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS BETWEEN (B)(6) 2020 WERE NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ALLEGED. 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 10747959 ↗
• MalfunctionOct 27, 2020Missing 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742064 ↗
• MalfunctionOct 8, 2020Nonstandard Device; Nonstandard Device

  THE CUSTOMER ALLEGED TO HAVE PURCHASED A CONTOUR METER IN THE US AND FOUND THAT THE METER WAS READING IN MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE METER IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10649760 ↗
• MalfunctionOct 5, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. ADDITIONALLY, THE ONE READING THAT WAS STORED IN THE METER'S MEMORY DID NOT HAVE DATE AND TIME STAMP ASSOCIATED WITH THE READING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ALLEGED. 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 10627316 ↗
• MalfunctionOct 5, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ALLEGED. 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 10627310 ↗
• MalfunctionSep 23, 2020Missing 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 10574911 ↗
• MalfunctionSep 17, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10547867 ↗
• MalfunctionSep 2, 2020Nonstandard Device; Nonstandard Device

  THE CUSTOMER ALLEGED TO HAVE PURCHASED A CONTOUR METER IN THE US AND FOUND THAT THE METER WAS READING IN 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 Known Impact Or Consequence To Patient

  MAUDE report 10483359 ↗
• MalfunctionSep 1, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT 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. REPLACEMENT METER KITS AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10478023 ↗
• MalfunctionAug 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 152 MG/DL AT 5:47 A.M. ON THE CONTOUR METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL 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 KITS AND TEST STRIPS WERE SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10413629 ↗
• MalfunctionAug 17, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS BETWEEN (B)(6) 2020 TO (B)(6) 2020 WERE NOT 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. REPLACEMENT METER KITS AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10413626 ↗
• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT HE ATTEMPTED TO PERFORM BLOOD GLUCOSE TESTING WITH HIS CONTOUR METER USING CONTOUR NEXT TEST STRIPS. THE CUSTOMER OBTAINED AN ERROR MESSAGE E4, WHICH IS INDICATIVE OF 'TEST STRIP NOT INSERTED CORRECTLY', BUT IN FACT THE CUSTOMER WAS USING THE INCORRECT TEST STRIP. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER WHICH USES THE CONTOUR NEXT TEST STRIPS. DURING THE FOLLOW-UP CALL, THE ADVOCATE REPORTED THAT SINCE THE REPLACEMENT METER TOOK A LONG TIME TO ARRIVE, THE CUSTOMER HAD A HYPERGLYCEMIC EPISODE AND PRESENTED WITH SYMPTOMS SUCH AS BLURRY VISION, CONFUSION, AND MARKED WEAKNESS. THE CUSTOMER ALSO GOT AN INFECTION ON HIS FOOT. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HE WAS TREATED WITH ANTIBIOTICS FOR THE INFECTION. ADDITIONALLY, THE CUSTOMER'S METFORMIN DOSAGE WAS CHANGED FROM 500 MG ONCE PER DAY TO 500 MG TWICE PER DAY. THE CUSTOMER WAS HOSPITALIZED FOR TWO WEEKS.

  Patient problems: Blurred Vision; Confusion/ Disorientation; Unspecified Infection; Weakness

  MAUDE report 10343273 ↗
• MalfunctionJun 12, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READING WAS NOT 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10147921 ↗
• MalfunctionApr 22, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HE CHANGED THE BATTERIES ON HIS CONTOUR METER ON (B)(6) 2020, AND SINCE LAST THREE DAYS HIS 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 9985914 ↗
• MalfunctionApr 15, 2020Missing 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 Known Impact Or Consequence To Patient

  MAUDE report 9963117 ↗

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---.