CONTOUR NEXTRecalls & reported problems across all models

We found 13 models of CONTOUR NEXT by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 971 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2017 and Sep 25, 2026 — classified as 143 injuries, 828 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (402 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 problems

CONTOUR NEXT models

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

• CONTOUR® NEXT 7312

  Artificial Pancreas Device System, Threshold Suspend
  283 reports
• CONTOUR® NEXT 7314

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  227 reports
• CONTOUR® NEXT 7311

  Glucose Dehydrogenase, Glucose
  101 reports
• CONTOUR® NEXT 7377

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  95 reports
• CONTOUR® NEXT 7308

  Glucose Dehydrogenase, Glucose
  93 reports
• CONTOUR® NEXT 9697

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  56 reports
• CONTOUR® NEXT 7309

  Artificial Pancreas Device System, Threshold Suspend
  37 reports
• CONTOUR® NEXT 7278

  Glucose Dehydrogenase, Glucose
  24 reports
• CONTOUR® NEXT 7313

  Glucose Dehydrogenase, Glucose
  21 reports
• CONTOUR® NEXT 7277

  Glucose Dehydrogenase, Glucose
  15 reports
• CONTOUR® NEXT 7310

  Glucose Dehydrogenase, Glucose
  9 reports
• CONTOUR® NEXT 7379

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  6 reports
• CONTOUR® NEXT 7315

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  4 reports

Recent CONTOUR NEXT adverse event reports

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

• InjurySep 25, 2026Low Readings

  The customer reported obtaining the following blood glucose results using a Contour® Next Link meter: 151 mg/dL at 5:38 p.m., 150 mg/dL at 5:50 p.m., 130 mg/dL at 6:08 p.m., and 93 mg/dL at 7:00 p.m. The customer also reported obtaining blood glucose results using a Contour® Next One meter of 107 mg/dL at 6:25 p.m., 92 mg/dL at 6:55 p.m., and 129 mg/dL at 7:08 p.m. The customer reported using both Contour® Next Link and Contour® Next One meters with Contour® Next test strips from lots 4JHEG01A and 4KHEG01C. The customer was unable to determine which test strip lot or meter-strip combination was associated with any individual blood glucose result. Based on the reported glucose readings, the customer administered 4 units of insulin. The customer subsequently reported symptoms attributed to hyperglycemia, described as feeling "out of his mind," disoriented, and collapsing. The customer was admitted to a hospital for two days and was treated with insulin and his usual medications. Additional medication details and dosages were not provided. Following treatment, the customer recovered and was discharged from the hospital.The customer was advised to return the device for evaluation.Repla

  Patient problems: Confusion/ Disorientation; Hyperglycemia

  MAUDE report 50898500 ↗
• InjurySep 25, 2026Low Readings

  Patient problems: Confusion/ Disorientation; Hyperglycemia

  MAUDE report 50898428 ↗
• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 196 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845330 ↗
• MalfunctionFeb 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER, AS HE PERFORMED A CONTROL TEST AND THE READING WAS AUTOMATICALLY MARKED AS A BLOOD RESULT IN THE METER'S MEMORY. SINCE THE CUSTOMER USED INCORRECT TESTING TECHNIQUE, DURING TROUBLESHOOTING, ANOTHER CONTROL TEST WAS PERFORMED USING THE CORRECT TESTING TECHNIQUE AND A READING OF 130 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL RESULT, AND SO THE READING WILL BE DISPLAYED AS A BLOOD 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 KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236185 ↗
• MalfunctionDec 12, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE OF THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT STORED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23791082 ↗
• InjuryOct 17, 2025High Readings; High Readings

  THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® NEXT EZ METER FOR EVALUATION. A REVIEW OF THE METER'S LOGBOOK SHOWED THE FOLLOWING BLOOD GLUCOSE READINGS RECORDED ON THE DATE OF THE EVENT (B)(6) 2025): 171 MG/DL AT 11:27 A.M., 115 MG/DL AT 12:25 P.M., 43 MG/DL AT 1:37 P.M., 110 MG/DL AT 7:59 P.M., 86 MG/DL AT 9:08 P.M., AND 60 MG/DL AT 11:29 P.M.

  Patient problems: Dizziness

  MAUDE report 23324187 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 176 MG/DL AT 9:38 A.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038438 ↗
• MalfunctionSep 12, 2025Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER OPENED A BOX OF CONTOUR® NEXT TEST STRIPS AND FOUND THAT THE BOTTLE WAS ALREADY OPEN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038436 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 186 MG/DL AT 4:34 P.M. WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED TO RETURN THE SUSPECTED DEVICE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038435 ↗
• MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 224 MG/DL AT 4:45 P.M. AND 204 MG/DL AT 4:46 P.M. THE METER DID NOT AUTOMATICALLY MARK THE READINGS AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. DURING TROUBLESHOOTING, ADDITIONAL THREE CONTROL TESTS WERE PERFORMED AND READINGS OF 124 MG/DL AT 5:18 P.M., 124 MG/DL AT 5:22 P.M. AND 127 MG/DL AT 5:24 P.M. WERE OBTAINED, WHICH WERE PROPERLY MARKED AS CONTROL TESTS. 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 23016613 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 205 MG/DL AT 12:56 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED 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 22993008 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 182 MG/DL AT 11:07 A.M., 142 MG/DL AT 11:11 A.M. AND 206 MG/DL AT 11:19 A.M. THE METER DID NOT AUTOMATICALLY MARK THE READINGS OF 182 MG/DL AND 206 MG/DL AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS 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 KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993000 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, TWO CONTROL TESTS WERE RUN AND READINGS OF 158 MG/DL AND 338 MG/DL WERE OBTAINED. THE METER DID NOT AUTOMATICALLY MARK THE READING OF 338 MG/DL AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD 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 KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992999 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 156 MG/DL AT 7:47 A.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992998 ↗
• MalfunctionAug 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 79 MG/DL AT 5:15 A.M. AND 72 MG/DL AT 5:17 A.M. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS 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 KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796328 ↗

Other Ascensia Diabetes Care US Inc. products

• 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
• CONTOUR NEXT LINK4 models · 45 reports