CONTOUR® NEXT 7313Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10301937313100), received between Feb 11, 2019 and Mar 3, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD GLUCOSE TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 69 MG/DL AT 1:31 P.M. 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504835 ↗
• MalfunctionJan 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF LO (INDICATIVE OF A READING BELOW 10 MG/DL) AT 4:48 P.M. WITH THE CONTOUR® NEXT GEN METER. 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265583 ↗
• MalfunctionJan 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 47 MG/DL AT 4:58 P.M. AND 420 MG/DL AT 5:03 P.M. WITH THE CONTOUR® NEXT GEN METER. THE CUSTOMER DID NOT PRESENT ANY SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA. 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 21265568 ↗
• MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT METER AT 12:34 P.M. AND OBTAINED A READING OF 20 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226670 ↗
• MalfunctionJul 1, 2023High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 124 MG/DL AT 3:39 P.M., 308 MG/DL AT 3:41 P.M., 407 MG/DL AT 3:43 P.M., AND 97 MG/DL AT 3:49 P.M. WITH THE CONTOUR NEXT ONE 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 17244207 ↗
• MalfunctionSep 15, 2022Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT HE OPENED A BOX OF THE CONTOUR NEXT TEST STRIPS AND 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 15428773 ↗
• MalfunctionMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER PERFORMED A BLOOD GLUCOSE TESTING AND OBTAINED A READING OF 154 MG/DL AT 2:54 P.M. ON THE CONTOUR NEXT EZ METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777274 ↗
• MalfunctionSep 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SHE OBTAINED BLOOD GLUCOSE READINGS OF 126 MG/DL AT 12:39 P.M., 115 MG/DL AT 12:49 P.M. AND 118 MG/DL AT 12:51 P.M. ON THE CONTOUR NEXT EZ METER. THE METER AUTOMATICALLY MARKED THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS CONTROL RESULTS WHEN ACCESSING THE METER'S MEMORY. THE CUSTOMER STATED THAT SHE HAD BEEN USING TEST STRIPS FROM LOT #S 9JPEF10B AND 9LPEC53A. HOWEVER, IT IS UNKNOWN WHICH READING WAS OBTAINED WITH WHICH LOT OF TEST STRIPS. 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 10566658 ↗
• MalfunctionSep 18, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE RECEIVED BLOOD GLUCOSE READINGS OF 125 MG/DL AT 11:04 P.M. ON THE CONTOUR NEXT EZ METER AND 453 MG/DL AT 11:09 A.M. ON A NON-ASCENSIA METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR THE EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553829 ↗
• MalfunctionSep 18, 2020Low Readings; Low Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 57 MG/DL AT 8:10 A.M., 27 MG/DL AT 8:15 A.M. AND 120 MG/DL AT 8:19 A.M. ON THE CONTOUR NEXT EZ METER. THE CUSTOMER DID NOT PRESENT ANY SYMPTOMS OF HYPOGLYCEMIA. 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 ADVOCATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553824 ↗
• MalfunctionAug 20, 2020Low Readings; Low Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 155 MG/DL AT 4:39 P.M. ON THE CONTOUR NEXT ONE METER AND 338 MG/DL AT 4:49 P.M. ON A NON-ASCENSIA 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 Known Impact Or Consequence To Patient

  MAUDE report 10432097 ↗
• MalfunctionAug 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF 291 MG/DL AT 11:29 A.M. WITH THE CONTOUR NEXT EZ METER WHILE USING TEST STRIPS FROM LOT # 9JPEG13A. HE PERFORMED A REPEAT TESTING AT 11:31 A.M. WITH THE CONTOUR NEXT ONE METER WHILE USING TEST STRIPS FROM LOT # 9LPEC54A AND OBTAINED A READING OF 94 MG/DL. 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 Known Impact Or Consequence To Patient

  MAUDE report 10361527 ↗
• MalfunctionJun 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 112 MG/DL AT 8:36 A.M. ON THE CONTOUR NEXT METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING 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 Known Impact Or Consequence To Patient

  MAUDE report 10184257 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC COMA DUE TO PANCREATIC CANCER. WHILE IN THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE COMPARED BETWEEN THE CONTOUR NEXT METER AND AN ALTERNATE BLOOD GLUCOSE METER WITHIN 4 MINUTES AND A DIFFERENCE OF 100 MG/DL WAS OBTAINED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162101 ↗
• MalfunctionMar 2, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT WITHIN 8 MINUTES, SHE OBTAINED BLOOD GLUCOSE READINGS OF 442 MG/DL ON A CONTOUR NEXT EZ METER AND 122 MG/DL ON A NON-ASCENSIA METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775638 ↗
• MalfunctionFeb 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED COMPARISONS BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT EZ METER AND A DIFFERENT METER AND RECEIVED DIFFERENCE OF 36 MG/DL. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9676503 ↗
• MalfunctionFeb 4, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED COMPARISON OF BLOOD GLUCOSE READINGS BETWEEN THE CONTOUR NEXT EZ AND CONTOUR METER WITHIN 10 MINUTES. THE READING ON THE CONTOUR NEXT EZ METER WAS 40 MG/DL LOWER COMPARED TO THAT OBTAINED ON THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. REPLACEMENT METER KITS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9666506 ↗
• MalfunctionNov 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 55 MG/DL AND 114 MG/DL ON TWO SEPARATE CONTOUR NEXT ONE METERS. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA, HOWEVER, HE DRANK JUICE TO LEVEL UP HIS BLOOD SUGAR LEVEL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296421 ↗
• MalfunctionJun 14, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 144 MG/DL, 143 MG/DL AND 173 MG/DL BETWEEN 1:35 P.M. AND 1:44 P.M. ON A CONTOUR NEXT ONE METER. HE ALSO PERFORMED TESTING ON A NON-ASCENSIA METER AND OBTAINED READING OF 83 MG/DL TWICE AT 1:40 P.M. AND 1:41 P.M. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699644 ↗
• MalfunctionMar 11, 2019High Readings; High Readings

  AT 7:30 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 189 MG/DL ON A CONTOUR NEXT EZ METER. UPON REPEAT TESTING AT 7:31 A.M. ON A DIFFERENT METER, A READING OF 102 MG/DL WAS OBTAINED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER, TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408052 ↗
• MalfunctionFeb 11, 2019High Readings; High Readings

  AT 1:37 P.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 187 MG/DL ON A CONTOUR NEXT ONE METER. AT 1:38 P.M., UPON REPEAT TESTING, A READING OF 97 MG/DL WAS OBTAINED ON A DIFFERENT METER. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324901 ↗

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-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, 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-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-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-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-0517-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rate

…and 8 more.