CONTOUR NEXT LINKRecalls & reported problems across all models

We found 4 models of CONTOUR NEXT LINK by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2018 and May 15, 2023 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CONTOUR NEXT LINK problems

CONTOUR NEXT LINK models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONTOUR® NEXT LINK 9632

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  22 reports
• CONTOUR® NEXT LINK 9740

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  12 reports
• CONTOUR® NEXT LINK 6203

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  10 reports
• CONTOUR® NEXT LINK 6207

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  1 report

Recent CONTOUR NEXT LINK adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 9, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A DIFFERENCE OF 72 MG/DL BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT LINK METER. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER WAS THIRSTY, UNAWARE, DIZZY, AND TIRED. THE CUSTOMER STATED THEY DID NOT SELF-TREAT THE SYMPTOMS OR REQUIRED MEDICAL INTERVENTION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCARDED THE DEVICE. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED 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: Dizziness; Hypoglycemia; Lethargy

  MAUDE report 11966753 ↗
• 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 ↗
• MalfunctionJun 1, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT SINCE LAST TWO MONTHS 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 DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10104599 ↗
• MalfunctionApr 6, 2020Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE BLOOD GLUCOSE READINGS BETWEEN THE CONTOUR NEXT LINK METER AND INSULIN PUMP WERE INCONSISTENT. THE CUSTOMER STATED THE SHE PERFORMED A TEST ON THE METER AND RECEIVED A READING, WHICH WAS TRANSFERRED AS LOW READING ON THE PUMP. THE CUSTOMER STATED THAT THE READING ON THE METER WAS NOT LOW. THE LOW READING FOR THE CUSTOMER IS BELOW 70 MG/DL. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. 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 9929699 ↗
• InjuryMar 27, 2020Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT SHE OBTAINED HIGH READINGS ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING AT 4:35 P.M. WAS 478 MG/DL. SHE PERFORMED ANOTHER TESTING AT 5:49 P.M. AND OBTAINED A READING OF 538 MG/DL. WHILE THE CUSTOMER WAS WORKING OUT IN THE MORNING, SHE EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA SUCH AS DRY MOUTH AND FEELING SICK. THE CUSTOMER REDUCED HER FOOD INTAKE. SINCE THE CUSTOMER'S INSULIN PUMP WAS NOT CONNECTED TO THE METER, THE CUSTOMER MANUALLY TOOK EXTRA INSULIN BASED ON THE HIGH READINGS. THE CUSTOMER ALLEGED THAT SHE DID NOT FEEL WELL EVEN AFTER TAKING EXTRA INSULIN AND EXPERIENCED SEVERE DEHYDRATION. SHE ASSOCIATED THE INCORRECT DOSE OF THE INSULIN WITH THE PUMP NOT BEING CONNECTED TO THE METER. AT 7:00 P.M., THE CUSTOMER WENT TO AN EMERGENCY ROOM. SHE OBTAINED A READING OF 442 MG/DL AT 7:21 P.M. AND WAS TREATED WITH INSULIN. THE CUSTOMER MENTIONED THAT SHE WAS PROVIDED A NEW PILL OF DESMOPRESSIN AT THE DOCTOR'S OFFICE TO IMPROVE HER DIABETES MANAGEMENT. SHE WAS DISCHARGED ON THE SAME NIGHT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.,

  Patient problems: Dehydration; Hyperglycemia

  MAUDE report 9889482 ↗
• MalfunctionMar 11, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE WAS IN A NURSING FACILITY WHEN HE PERFORMED COMPARISON TESTING BETWEEN HIS TWO CONTOUR NEXT LINK METERS AND THE NURSING FACILITY'S METER. THE CUSTOMER STATED THAT BLOOD GLUCOSE READINGS ON BOTH THE CONTOUR NEXT LINK METERS WERE 20 TO 50 MG/DL HIGHER COMPARED TO THAT OBTAINED ON THE NURSING FACILITY'S 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. 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 9819245 ↗
• 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 ↗
• MalfunctionJan 7, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HE DROPPED HIS CONTOUR NEXT LINK METER AFTER WHICH HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE 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 9558537 ↗
• 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 ↗
• MalfunctionOct 22, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS BETWEEN (B)(6) 2019 TO (B)(6) 2019 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 9219208 ↗
• MalfunctionOct 1, 2019High Readings; High Readings

  AT 8:16 P.M., THE CUSTOMER PERFORMED BLOOD GLUCOSE TESTS WITH THE CONTOUR NEXT LINK METER AND A NON-ASCENSIA METER OBTAINING READINGS OF 261 MG/DL AND 119 MG/DL RESPECTIVELY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, THEREFORE, THE TEST STRIPS ARE NOT EXPECTED TO BE RETURNED. 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 9138682 ↗

Other Ascensia Diabetes Care US Inc. products

• CONTOUR NEXT13 models · 971 reports
• CONTOUR NEXT EZ3 models · 206 reports
• CONTOUR NEXT ONE6 models · 184 reports
• CONTOUR9 models · 156 reports
• CONTOUR NEXT GEN5 models · 85 reports · 1 recall
• CONTOUR NEXT LINK 2.42 models · 87 reports