CONTOUR® NEXT 7310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10301937310253), received between Jun 2, 2017 and Nov 5, 2020 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “High Readings” (5 reports).

23 other recalls cover devices cleared under the same FDA submission (K121190, K160430, K162336, K191286, K193407, K210687, K223293, K241787, P150001, P160017); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 380 MG/DL ON THE CONTOUR LINK 2.4 METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA SUCH AS NAUSEA, SHORTNESS OF BREATH, AND WEAKNESS. SHE TOOK INSULIN BOLUS AND CONTINUED EXPERIENCING SYMPTOMS. AN HOUR LATER, THE CUSTOMER WENT TO THE HOSPITAL WHERE SHE OBTAINED A READING OF 580 MG/DL. THE CUSTOMER WAS ADMITTED TO AN INTENSIVE CARE UNIT FOR FIVE DAYS AND WAS GIVEN AN INSULIN DRIP AND ANTIBIOTICS AFTER WHICH SHE RECOVERED WELL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Fatigue; Hyperglycemia; Nausea

  MAUDE report 10790986 ↗
• MalfunctionOct 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN A BLOOD GLUCOSE TEST AT 1:21 P.M. ON HIS CONTOUR NEXT EZ METER AND OBTAINED A READING OF 137 MG/DL. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL 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 10612162 ↗
• MalfunctionNov 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER RECEIVED A BLOOD GLUCOSE READING ON THE CONTOUR NEXT LINK METER THAT WAS 100 MG/DL DIFFERENT THAN THE READING OBTAINED ON THE PHYSICIAN'S METER. THE SPECIFIC READINGS WERE NOT PROVIDED. DEPENDING ON THE ACTUAL RESULTS, THE DIFFERENCE BETWEEN THE READINGS COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090799 ↗
• MalfunctionNov 1, 2018High Readings; High Readings

  THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 170 MG/DL ON A CONTOUR NEXT LINK 2.4 METER. BASED ON THIS READING, SHE INJECTED 2.265 UNITS OF INSULIN. AFTER TAKING INSULIN, HER BLOOD SUGAR LEVEL STARTED TO DROP AND SHE FELT HYPOGLYCEMIC SYMPTOMS SUCH AS TIREDNESS AND CLAMMY SKIN. WITHIN A MINUTE OF OBTAINING THE INITIAL READING, SHE CHECKED HER GLUCOSE READING ON A DIFFERENT METER AND OBTAINED A READING OF 49 MG/DL. SHE TOOK CARBOHYDRATES TO STABILIZE HER BLOOD SUGAR LEVEL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: Hypoglycemia; Sweating

  MAUDE report 8028571 ↗
• MalfunctionSep 27, 2018High Readings; High Readings

  AT 7:03 P.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 87 MG/DL ON A CONTOUR NEXT METER. AT 7:10 P.M., THE CUSTOMER PERFORMED A RETESTING ON A CONTOUR NEXT EZ METER AND OBTAINED A READING WITH THE DISPLAY "HIGH". THE DIFFERENCE BETWEEN THE READINGS CAN FALL IN THE "D" OR "E" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT ALLEGED. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE PRODUCT FOR EVALUATION. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915211 ↗
• MalfunctionAug 30, 2018High Readings; High Readings

  AT 3:37 P.M., THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 600 MG/DL ON A CONTOUR NEXT LINK METER. AT 3:38 P.M., THE CUSTOMER PERFORMED REPEAT TESTING ON A DIFFERENT METER AND OBTAINED A READING OF 247 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW STRIPS, METER AND CONTROLS SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7833010 ↗
• MalfunctionAug 29, 2018High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 254 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER PERFORMED REPEAT TESTING ON TWO ALTERNATE METERS AND THE READINGS WERE 86 MG/DL AND 84 MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW STRIPS, METER AND CONTROLS SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7828115 ↗
• MalfunctionMay 16, 2018High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 169MG/DL ON THE CONTOUR NEXT LINK 2.4, RETESTED ON A DIFFERENT METER AND THE READING WAS 88MG/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. THE STRIPS WERE NOT EXPECTED TO BE RETURNED FOR EVALUATION. A NEW KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518103 ↗
• InjuryJun 2, 2017Insufficient Device Problem Information

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 23MG/DL ON THE CONTOUR NEXT USB AND FELT SHAKY, WHICH SHE STATED WAS AN INDICATION OF LOW BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR INVESTIGATION. NEW METER AND STRIPS WERE SENT TO HER.

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 6608671 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121190, K160430, K162336, K191286, K193407, K210687, K223293, K241787, P150001, P160017. One submission often covers many models, so check the product and lot details in each record.

• Z-2981-2026 · Jul 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
• Z-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1266-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1261-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1265-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-0003-2025 · Jul 31, 2024 · Open, Classified
  MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G
• Z-0001-2025 · Jul 31, 2024 · Open, Classified
  MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
• Z-2211-2023 · May 19, 2023 · Open, Classified
  Contour next GEN Blood Glucose Monitoring System
• Z-0193-2023 · Sep 20, 2022 · Open, Classified
  Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
• Z-0855-2022 · Jan 27, 2022 · Open, Classified
  MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-18
• Z-1771-2021 · Mar 15, 2021 · Open, Classified
  MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE
• Z-0516-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under

…and 8 more.