CONTOUR® NEXT LINK 9632Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00301939632011), received between Jun 14, 2018 and Jun 9, 2021 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 16, 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 8901216 ↗
• MalfunctionJul 19, 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8808123 ↗
• InjuryJun 5, 2019High Readings; High Readings

  THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 40 MG/DL AND 184 MG/DL ON A CONTOUR NEXT LINK METER. THE CUSTOMER REFUSED TO PROVIDED ANY ADDITIONAL INFORMATION. THE CUSTOMER REFUSED 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 Information

  MAUDE report 8671183 ↗
• MalfunctionJun 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THREE MONTHS PRIOR TO THE CALL, HE RECEIVED A DIFFERENCE OF 130 MG/DL BETWEEN BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT LINK AND CONTOUR NEXT ONE METER. THE SPECIFIC READINGS WERE NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER. SINCE THE TEST STRIPS DETAILS PROVIDED BY THE CUSTOMER WERE NOT FROM THE TIME OF THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8671181 ↗
• MalfunctionMar 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 41 AND 241 MG/DL ON A CONTOUR NEXT LINK METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA. THERE WAS NO ALLEGATION OF ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. 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 8389624 ↗
• MalfunctionNov 29, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8114702 ↗
• MalfunctionNov 14, 2018No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT HIS CONTOUR NEXT LINK METER HAD A FROZEN DISPLAY AND HE WAS UNABLE TO MANUALLY TURN IT OFF. DURING TROUBLESHOOTING, THE CUSTOMER WAS ASKED TO RESET THE METER AND IT TURNED OFF. THE CUSTOMER INSERTED A TEST STRIP INTO THE METER PORT AND THE DISPLAY TURNED ON. AT 6:05 P.M., THE CUSTOMER PERFORMED A TEST AND OBTAINED A BLOOD GLUCOSE READING OF 426 MG/DL. AFTER THIS READING, THE CUSTOMER WAS HAVING SYMPTOMS SUCH AS FEELING SICK TO HIS STOMACH, JOINT SORENESS, COTTON MOUTH, AND THIRSTINESS. AT AROUND 6:00 P.M., THE CUSTOMER TOOK 6.8 UNITS OF HUMALOG. AFTER 30 MINUTES, THE CUSTOMER'S SYMPTOMS SUBSIDED AND HE WAS FEELING FINE. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: Arthralgia; Hyperglycemia; Nausea

  MAUDE report 8068590 ↗
• MalfunctionOct 3, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE OF THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. NO ADVERSE EVENT ALLEGED. 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 7929925 ↗
• InjurySep 28, 2018Low Readings; Low Readings

  THE ADVOCATE OF THE CUSTOMER REPORTED THAT INACCURATE READINGS WERE OBTAINED ON THE CONTOUR NEXT LINK METER. THE CUSTOMER SELF-MEDICATED BASED ON THE LOW READINGS AND EXPERIENCED ADVERSE REACTIONS. NO SPECIFIC READINGS HAVE BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE EVENT. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. 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 Information

  MAUDE report 7917766 ↗
• MalfunctionSep 17, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE OF THE CUSTOMER REPORTED THAT THE BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. NO ADVERSE EVENT ALLEGED. 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 7881193 ↗
• MalfunctionSep 12, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE OF THE CUSTOMER REPORTED THAT THE BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. NO ADVERSE EVENT ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868343 ↗
• MalfunctionSep 7, 2018High Readings; High Readings

  AT 2:38 P.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 418 MG/DL ON A CONTOUR NEXT LINK METER. WITHIN 10 MINUTES, THE CUSTOMER PERFORMED RETESTING ON A DIFFERENT CONTOUR NEXT METER AND OBTAINED A READING OF 120 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. SPECIFIC STRIP INFORMATION WAS NOT PROVIDED. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION. THE PRODUCT IS NOT EXPECTED TO BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854965 ↗
• MalfunctionAug 17, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE STATED THE CUSTOMER'S CONTOUR NEXT LINK IS NOT STORING ALL OF HIS BLOOD GLUCOSE READINGS IN MEMORY COMPARED TO THE LOGBOOK HE HAS BEEN KEEPING. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794744 ↗
• MalfunctionAug 17, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE STATED THE CUSTOMER'S CONTOUR NEXT LINK IS NOT STORING ALL OF HIS BLOOD GLUCOSE READINGS IN MEMORY COMPARED TO THE LOGBOOK HE HAS BEEN KEEPING. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794735 ↗
• MalfunctionJul 23, 2018Missing Test Results; Missing Test Results

  THE CUSTOMER STATED ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT LINK. DURING THE CALL SHE RAN A BLOOD GLUCOSE TEST AND WAS NOT ABLE TO FIND THAT READING IN MEMORY EITHER. NO ADVERSE EVENT WAS ALLEGED. 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 7709869 ↗
• MalfunctionJul 23, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE STATED HER DAUGHTER TESTS HER BLOOD 6 TIMES A DAY ON THE CONTOUR NEXT LINK. ONE OF THOSE DAYS THERE WAS ONLY ONE READING IN THE MEMORY OF THE METER, AND THE MOTHER WITNESSED THE DAUGHTER PERFORMING 6 TESTS. THE ADVOCATE ALSO RAN A BLOOD TEST DURING THE CALL, AND WAS NOT ABLE TO SEE THAT READING IN THE MEMORY EITHER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7709862 ↗
• InjuryJun 14, 2018Low Readings; Low Readings

  THE ADVOCATE STATED HER HUSBAND HAD BEEN GETTING WHAT HE CONSIDERED NORMAL BLOOD GLUCOSE READINGS ON THE CONTOUR NEXT LINK, BUT WAS TAKEN TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS. HE WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS, AND WAS GIVEN INSULIN IV. FURTHER INFORMATION WAS NOT PROVIDED. THE STRIPS WERE NOT EXPECTED TO BE RETURNED FOR EVALUATION. STRIP INFORMATION WAS NOT PROVIDED. PRODUCT WAS NOT REPLACED.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 7600659 ↗