CONTOUR® NEXT LINK 6203Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00301936203016), received between Jul 24, 2018 and May 15, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (6 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 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 LINK 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 16930873 ↗
• MalfunctionSep 18, 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 470 MG/DL AT 1:35 P.M. AND 81 MG/DL AT 1:39 P.M. ON THE CONTOUR NEXT LINK 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 ADVOCATE. THE TEST STRIPS INFORMATION PROVIDED BY THE CUSTOMER DID NOT BELONG TO THIS EVENT. THEREFORE, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553826 ↗
• MalfunctionJun 4, 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 NEXT LINK METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCONNECTED THE CALL. THEREFORE, THE CUSTOMER COULD NOT BE ADVISED TO RETURN THE DEVICE FOR EVALUATION AND REPLACEMENT DEVICE COULD NOT BE OFFERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10119007 ↗
• MalfunctionFeb 14, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT SOME OF HER READINGS FROM (B)(6) 2020 TO (B)(6) 2020 WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. THE CUSTOMER MENTIONED THAT THE READING FROM (B)(6) 2020 WERE PROPERLY STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712544 ↗
• MalfunctionJan 28, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE VISITED THE HOSPITAL AS SHE WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. THE CUSTOMER STATED THAT SHE PERFORMED BLOOD GLUCOSE TESTING ON HER CONTOUR NEXT LINK METER AND HOSPITAL'S METER. THE READING ON HER CONTOUR NEXT LINK METER WAS 40 MG/DL HIGHER COMPARED TO THAT OBTAINED ON THE HOSPITAL'S METER. BOTH READINGS WERE OBTAINED WITHIN 10 MINUTES. NO SPECIFIC READINGS WERE OBTAINED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Hyperglycemia

  MAUDE report 9638135 ↗
• MalfunctionJan 17, 2020Low Readings; Low Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER WAS AT THE HOSPITAL FOR AN EVENT UNRELATED TO DIABETES. THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING THE CONTOUR NEXT LINK METER AND A READING OF 165 MG/DL WAS OBTAINED, WHEREAS THE READING OBTAINED WITH THE LABORATORY TESTING WAS 360 MG/DL. THERE IS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. A REPLACEMENT METER KIT WAS 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 9601384 ↗
• MalfunctionNov 25, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371321 ↗
• MalfunctionAug 21, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 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 8916512 ↗
• MalfunctionMay 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 568 MG/DL ON HER CONTOUR NEXT LINK METER. SHE HAD NO SYMPTOMS OF HYPERGLYCEMIA. BASED ON THE HIGH READING, SHE RECEIVED 8.7 UNITS OF INSULIN FROM HER PUMP. THE CUSTOMER PERFORMED REPEAT TESTING WITHIN 10 MINUTES USING ANOTHER CONTOUR NEXT LINK METER AND OBTAINED A READING OF 228 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THAT SHE USED ALL THE TEST STRIPS FROM THE AFFECTED LOT AND DISCARDED THE BOTTLE OF STRIPS AND THEREFORE, TEST STRIPS ARE NOT EXPECTED TO BE RETURNED. A REPLACEMENT METER WAS 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 8568412 ↗
• MalfunctionJul 24, 2018Missing Test Results; Missing Test Results

  THE CUSTOMER STATED THE CONTOUR NEXT LINK HAD NOT STORED HER BLOOD GLUCOSE READINGS SINCE THE BEGINNING OF JUNE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO HER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713379 ↗