CONTOUR® NEXT EZ 7252Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00301937252013), received between Dec 6, 2017 and Nov 10, 2023 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (41 reports).

1 other recall cover devices cleared under the same FDA submission (K111268, K130265, K162336); 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 18114550 ↗
• MalfunctionJul 1, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 17244208 ↗
• MalfunctionMay 9, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 16894589 ↗
• MalfunctionApr 13, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 16735694 ↗
• MalfunctionMar 27, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619422 ↗
• MalfunctionMay 4, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 14278752 ↗
• MalfunctionApr 19, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 14142613 ↗
• MalfunctionApr 12, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 14084138 ↗
• MalfunctionMar 16, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 13789867 ↗
• InjuryMar 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE CALLED ON BEHALF OF THEIR SON TO REPORT THAT THEY OBTAINED INACCURATE READING WITH THEIR CONTOUR NEXT EZ METER. THE ADVOCATE STATED THAT THE CUSTOMER RECEIVED INCORRECT DOSAGE OF INSULIN BASED ON THE INACCURATE READING AND WAS HOSPITALIZED. NO SPECIFIC READING WAS PROVIDED, HOWEVER, THE ADVOCATE STATED THAT ALL THE READINGS OBTAINED IN THE HOSPITAL SHOWED A DIFFERENCE OF 20 MG/DL TO 40 MG/DL WHEN COMPARED WITH THE CONTOUR NEXT EZ METER. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE ADVOCATE. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 13685434 ↗
• MalfunctionSep 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 NEXT EZ 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 12468410 ↗
• MalfunctionAug 2, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259204 ↗
• MalfunctionJul 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HIS READINGS WERE BEING INCORRECTLY STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THE CUSTOMER PROVIDED AN EXAMPLE, WHERE A READING OF 159 MG/DL WAS STORED AS 196 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 12165655 ↗
• MalfunctionJul 1, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 12098740 ↗
• MalfunctionJun 16, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 12009023 ↗
• MalfunctionApr 27, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 11733210 ↗
• InjuryFeb 26, 2021No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT HER CONTOUR NEXT EZ METER WAS PRODUCING E11 ERROR MESSAGES, INDICATIVE OF A TESTING TECHNIQUE ERROR. THE CUSTOMER CONTACTED ASCENSIA DIABETES CARE TO RECEIVE THE REPLACEMENT METER. DURING THE FOLLOW-UP CALL, THE CUSTOMER STATED THAT SINCE SHE DID NOT RECEIVE THE REPLACEMENT PRODUCT AND WAS UNABLE TO PERFORM TESTING, SHE TOOK MORE THAN USUAL MEDICATION AND COULD NOT WAKE UP. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER HAD BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11386151 ↗
• MalfunctionFeb 16, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 11333224 ↗
• MalfunctionFeb 2, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED THE ASCENSIA CUSTOMER SERVICE TO RECEIVE HELP WITH HER CONTOUR NEXT EZ METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT HER PREVIOUS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. HOWEVER, WHEN THE TESTING WAS PERFORMED BY THE CUSTOMER WHILE ON THE CALL, THE READING WAS 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268110 ↗
• MalfunctionNov 3, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 10777294 ↗
• MalfunctionOct 13, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READING WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 10670428 ↗
• MalfunctionSep 1, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS FROM (B)(6) 2020 AND (B)(6) 2020 WERE NOT STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 10478016 ↗
• MalfunctionJul 2, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ 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 10225027 ↗
• MalfunctionMar 23, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT SCORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865722 ↗
• MalfunctionMar 2, 2020Missing Test Results; Missing Test Results

  A PHARMACIST CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT EZ METER. THERE WERE NO READINGS IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111268, K130265, K162336. One submission often covers many models, so check the product and lot details in each record.

• Z-2482-2015 · Jun 22, 2015 · Terminated
  Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary