CONTOUR NEXT LINK 2.4Recalls & reported problems across all models

We found 2 models of CONTOUR NEXT LINK 2.4 by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and May 1, 2025 — classified as 12 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (50 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 2.4 problems

CONTOUR NEXT LINK 2.4 models

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

• CONTOUR® NEXT LINK 2.4 6260

  Artificial Pancreas Device System, Threshold Suspend
  74 reports
• CONTOUR® NEXT LINK 2.4 6262

  Artificial Pancreas Device System, Threshold Suspend
  13 reports

Recent CONTOUR NEXT LINK 2.4 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT LINK 2.4 METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S 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 21942070 ↗
• MalfunctionFeb 4, 2025High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR® NEXT LINK 2.4 METER AND OBTAINED READINGS OF 415 MG/DL, 111 MG/DL AND 400 MG/DL WITHIN 10 MINUTES. THE CUSTOMER WAS FEELING DIZZY AND CALLED AN EMERGENCY SERVICE. THE PARAMEDICS PERFORMED TESTING WITH THE CUSTOMER'S METER. NO SPECIFIC READING WAS PROVIDED. THE CUSTOMER TOOK ORANGE JUICE AND AFTER 40 MINUTES, ANOTHER TESTING WAS PERFORMED WITH THE PARAMEDICS' METER AND A READING OF 288 MG/DL WAS OBTAINED. THE CUSTOMER RECOVERED WELL. 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: Dizziness

  MAUDE report 21305626 ↗
• MalfunctionAug 21, 2024Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE THE CONTOUR NEXT LINK 2.4 METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT HER 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 20017858 ↗
• MalfunctionOct 9, 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 LINK 2.4 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 17895318 ↗
• MalfunctionSep 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 2.4 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 17755387 ↗
• InjuryJul 18, 2023High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT LINK 2.4 METER WERE NOT IN AGREEMENT WITH THE SYMPTOMS. NO SPECIFIC READINGS WERE PROVIDED ASSOCIATED WITH THE EVENT. AROUND 2 MONTHS AGO, THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA WHICH WAS DESCRIBED AS BEING CONFUSED AND DIZZY. THE CUSTOMER FAINTED AND BROKE HER PELVIS BONE. IT IS UNKNOWN IF THE CUSTOMER PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT LINK 2.4 METER PRIOR TO THE EVENT. HOWEVER, THE READING ON THE CUSTOMER'S INSULIN PUMP WAS 40 MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HER BLOOD GLUCOSE LEVELS WERE CONSTANTLY MONITORED AND SHE WAS TREATED FOR THE BROKEN PELVIS. NO TREATMENT DETAILS WERE PROVIDED. THE CUSTOMER WAS HOSPITALIZED FOR TWO MONTHS AND HAS RECOVERED WELL. SINCE THE STRIP INFORMATION PROVIDED WAS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Confusion/ Disorientation; Dizziness; Hip Fracture; Syncope/Fainting

  MAUDE report 17341777 ↗
• InjuryApr 11, 2023High Readings; High Readings

  THE CUSTOMER ALLEGED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 700 MG/DL AND 70 MG/DL WITH THE CONTOUR NEXT LINK 2.4 METER. THE CONTOUR NEXT LINK 2.4 METER HAS THE HIGHEST MEASUREMENT RANGE OF 600 MG/DL. THE READINGS ABOVE 600 MG/DL WILL BE DISPLAYED AS HI READINGS IN THE METER. THE CUSTOMER STATED THAT HE WAS HOSPITALIZED BECAUSE HE EXPERIENCED HYPOGLYCEMIA. HOWEVER, THE CUSTOMER WAS TREATED WITH ANTIBIOTICS AND CONTINUOUS INSULIN DRIP IN THE HOSPITAL WHICH IS A TREATMENT FOR HYPERGLYCEMIA. THE BLOOD GLUCOSE TEST PERFORMED IN THE HOSPITAL PRODUCED A READING OF 110 MG/DL. NO FURTHER EVENT DETAILS WERE PROVIDED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Hypoglycemia

  MAUDE report 16714501 ↗
• MalfunctionFeb 13, 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 LINK 2.4 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 16363480 ↗
• MalfunctionSep 29, 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 LINK 2.4 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 15502446 ↗
• MalfunctionJun 21, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER FROM (B)(6) REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 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 14756088 ↗
• InjuryMay 24, 2022Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 271 MG/DL AT 2:01 P.M. WITH THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS SUCH AS NAUSEA AND DEHYDRATION. THE CUSTOMER TOOK 1 UNIT OF INSULIN BASED ON THE METER READING. SINCE THE CUSTOMER WAS FEELING UNWELL, SHE WENT TO THE HOSPITAL WHERE SHE STAYED FOR TWO DAYS AND RECOVERED WELL. IN THE HOSPITAL, ADDITIONAL BLOOD GLUCOSE TESTING WAS PERFORMED WITH THE CUSTOMER'S METER AND A NON-ASCENSIA METER, WHICH GAVE READINGS OF 278 MG/DL AT 2:23 P.M. AND 353 MG/DL AT 2:30 P.M. RESPECTIVELY. NO FURTHER EVENT DETAILS WERE PROVIDED. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Dehydration; Nausea

  MAUDE report 14489516 ↗
• MalfunctionJan 12, 2022Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT SOME OF THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 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 13235854 ↗
• InjurySep 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED INACCURATE READINGS WITH THE CONTOUR NEXT LINK 2.4 METER. NO SPECIFIC READING FROM THE EVENT WAS PROVIDED. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA AND TOOK INSULIN. THE CUSTOMER FELT SICK AFTER ADMINISTERING INSULIN AND WENT TO THE HOSPITAL. THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER EVENT DETAILS. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT 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: Hyperglycemia

  MAUDE report 12468406 ↗
• InjurySep 14, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE CONSUMED THE REGULAR AMOUNT OF CARBOHYDRATE AND THEN PERFORMED A BLOOD GLUCOSE TEST WITH THE CONTOUR NEXT LINK 2.4 METER PRIOR TO GOING TO SLEEP AND HIS SUGAR LEVEL WAS FINE. NO SPECIFIC READING WAS PROVIDED. TWO HOURS LATER, THE CUSTOMER WOKE UP IN THE MIDDLE OF THE NIGHT AS HE WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS UNAWARENESS AND DIZZINESS, AND THEN HE FAINTED. WHEN THE CUSTOMER FAINTED, HE FELL DOWN A FLIGHT OF STAIRS. THE EMERGENCY SERVICE WAS CALLED AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. THE CUSTOMER WAS GIVEN GLUCOSE INTRAVENOUSLY. THE CUSTOMER HAD ALSO BROKEN HIS ANKLE WHEN HE FELL DOWN THE STAIRS AND A CAST WAS PLACED ON HIS ANKLE. THE CUSTOMER'S INSULIN PUMP WAS REMOVED AND FOR 5 DAYS HE WAS GIVEN INSULIN THROUGH INJECTIONS. 5 DAYS LATER, THE CUSTOMER WAS REPORTED TO BE EXPERIENCING CONFUSION. THE CUSTOMER WAS BEING MONITORED AND CONTINUED TO RECEIVE INTRAVENOUS GLUCOSE. THE CUSTOMER WAS HOSPITALIZED FOR 7 DAYS AND RECOVERED WELL. 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 PR

  Patient problems: Bone Fracture(s); Confusion/ Disorientation; Dizziness; Hypoglycemia; Syncope/Fainting

  MAUDE report 12468405 ↗
• MalfunctionSep 1, 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 LINK 2.4 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 12406332 ↗

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 LINK4 models · 45 reports