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CONTOUR® NEXT LINK 9740Recalls & reported problems

Ascensia Diabetes Care US Inc. · Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case. · Class 1

Adverse event reports
12
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00301939740013), received between Mar 5, 2018 and Mar 27, 2020 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (9 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

Device problems

  • Missing Test Results9
  • High Readings2
  • Wireless Communication Problem1

Patient problems

  • No Known Impact Or Consequence To Patient10
  • Dehydration1
  • Hyperglycemia1
  • Hypoglycemia1
  • Loss of consciousness1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • 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 ↗
  • 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 ↗
  • 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 ↗
  • MalfunctionSep 2, 2019Missing Test Results; Missing Test Results

    AN ADVOCATE REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK METER. DURING THE CALL, UPON THE CUSTOMER SERVICE AGENT'S REQUEST, THE ADVOCATE RAN A BLOOD TEST AND THE READING WAS PROPERLY STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE METER FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SEND TO THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8953596 ↗
  • MalfunctionJun 10, 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. REPLACEMENT METER AND TEST STRIPS WERE SEND TO THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8683504 ↗
  • MalfunctionDec 17, 2018Missing Test Results; Missing Test Results

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

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8170549 ↗
  • MalfunctionNov 20, 2018Missing Test Results; Missing Test Results

    ON (B)(6) 2018, THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 166 MG/DL ON A CONTOUR NEXT LINK METER. WHEN THE CUSTOMER REVIEWED THE METER MEMORY, HE FOUND THAT THIS READING WAS NOT STORED IN THE METER MEMORY. THE CUSTOMER STATED THAT HE PERFORMED TESTS WITH THIS METER OVER ONE WEEK AND NONE OF THE READINGS WERE STORED IN THE MEMORY OF THE METER. THE LAST READING STORED IN THE METER WAS FROM (B)(6) 2018. NO ADVERSE EVENT 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 8090801 ↗
  • MalfunctionOct 26, 2018Missing Test Results; Missing Test Results

    THE CUSTOMER STATED THAT HER 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 8009718 ↗
  • MalfunctionOct 24, 2018Missing Test Results; Missing Test Results

    THE CUSTOMER STATED THAT THE BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF A CONTOUR NEXT LINK METER. NO ADVERSE EVENT ALLEGED. THE ADVOCATE 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 8000605 ↗
  • InjuryAug 31, 2018High Readings; High Readings

    AT 6:15 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 482 MG/DL ON HIS CONTOUR NEXT LINK METER. THE CUSTOMER MADE A CORRECTION BOLUS FOR 12 UNITS OF INSULIN, AS SUGGESTED BY HIS INSULIN PUMP. AT 8:34 A.M., THE CUSTOMER PERFORMED ANOTHER TEST AND OBTAINED A BLOOD GLUCOSE READING OF 388 MG/DL. AS THE READING WAS STILL HIGH, THE CUSTOMER MADE ANOTHER CORRECTION BOLUS FOR 4.4 UNITS OF INSULIN. THE CUSTOMER STARTED PRESENTING THE SYMPTOMS OF LOW BLOOD GLUCOSE LEVEL. SPECIFIC SYMPTOMS WERE NOT PROVIDED. TWO HOURS LATER, WHILE THE CUSTOMER WAS AT THE HOSPITAL FOR HIS REGULAR VISIT, HE PASSED OUT. AT 10:17 A.M., HIS METER GAVE A BLOOD GLUCOSE READING OF 168 MG/DL. THE CUSTOMER WAS ADMINISTERED WITH AN UNKNOWN DOSE OF GLUCOSE THROUGH PARENTERAL MODE. THE CUSTOMER WAS TESTED WITH THE PHYSICIAN'S METER AND A BLOOD GLUCOSE READING OF 265 MG/DL WAS OBTAINED. AT AN UNKNOWN TIME, THE CUSTOMER PERFORMED A TESTING ON HIS METER AND OBTAINED A BLOOD GLUCOSE READING OF 600 MG/DL. NO ACTION WAS TAKEN BASED ON THIS READING. STRIPS WERE NOT EXPECTED TO BE RETURNED. STRIP INFORMATION WAS NOT PROVIDED. REPLACEMENT METER WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS R

    Patient problems: Hypoglycemia; Loss of consciousness

    MAUDE report 7839449 ↗
  • MalfunctionMar 5, 2018Missing Test Results; Missing Test Results

    ADVOCATE STATED HER DAUGHTER'S CONTOUR NEXT LINK DID NOT SHOW THE PREVIOUS MONTH'S BLOOD GLUCOSE READINGS. NO ADVERSE EVENT WAS ALLEGED. 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 7312577 ↗
  • MalfunctionMar 5, 2018Missing Test Results; Missing Test Results

    THE CUSTOMER INITIALLY CALLED FOR ASSISTANCE WITH HIGH READINGS. DURING THE CALL SHE WAS UNABLE TO SEE HER BLOOD GLUCOSE READINGS IN THE MEMORY OF THE CONTOUR NEXT LINK. THE READINGS WERE FROM THE PREVIOUS WEEK. 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 7312576 ↗

Other Single (Specified) Analyte Controls (Assayed And Unassayed) devices

All Single (Specified) Analyte Controls (Assayed And Unassayed) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.