CONTOUR® NEXT 7277Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10301937277358), received between Apr 20, 2018 and Sep 12, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “High Readings” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 1, 2025Unsealed 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 21942051 ↗
• MalfunctionNov 2, 2024Unsealed 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 20594324 ↗
• MalfunctionJun 10, 2024High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF 442 MG/DL AT 12:23 P.M. WITH THE CONTOUR NEXT GEN METER AND WITHIN TWO MINUTES, THE READING WITH THE LABORATORY TESTING WAS 200 MG/DL. THE CUSTOMER WAS FEELING TIRED AND ASSOCIATED THE SYMPTOM WITH HYPERGLYCEMIA. THE CUSTOMER WAS GIVEN METFORMIN BASED ON THE LABORATORY TEST, AND RECOVERED WELL. 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: Lethargy

  MAUDE report 19499274 ↗
• MalfunctionJan 25, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF HI (INDICATIVE OF A READING ABOVE 600 MG/DL) AT 12:24 P.M. AND 132 MG/DL AT 12:30 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343444 ↗
• MalfunctionSep 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD TEST ON THE CONTOUR NEXT 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. NO SPECIFIC READING WAS PROVIDED. 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 12406440 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 277 MG/DL AT 9:49 P.M., 146 MG/DL AT 9:53 P.M. AND 486 MG/DL AT 9:54 P.M. ON THE CONTOUR NEXT METER. 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 10547863 ↗
• MalfunctionJun 8, 2020Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT THE BOTTLE OF CONTOUR NEXT TEST STRIPS WAS ALREADY OPEN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER RETURNED THE BOTTLE OF TEST STRIPS TO PHARMACY FROM WHERE SHE PURCHASED THE BOTTLE OF TEST STRIPS. THEREFORE, THE BOTTLE OF TEST STRIPS IS NOT EXPECTED TO BE RETURNED. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128831 ↗
• MalfunctionMar 23, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 8:34 A.M., HE OBTAINED BLOOD GLUCOSE READINGS OF 200 MG/DL ON THE CONTOUR NEXT EZ METER AND 100 MG/DL ON A NON-ASCENSIA METER. 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 9865724 ↗
• InjuryMar 16, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT ON (B)(6) 2020, HE HAD PROBLEM SPEAKING, WHICH IS A SYMPTOM OF HYPOGLYCEMIA FOR HIM. THE CUSTOMER WENT TO THE HOSPITAL WHERE A COMPARISON TESTING WAS PERFORMED, WHICH GAVE BLOOD GLUCOSE READINGS OF 70 MG/DL ON THE CONTOUR NEXT METER, 73 MG/DL ON THE CONTOUR NEXT USB METER AND 37 MG/DL ON THE HOSPITAL METER. ALL READINGS WERE OBTAINED WITHIN 10 MINUTES. THE CUSTOMER RECEIVED DEXTROSE SOLUTION IN THE HOSPITAL TO RAISE HIS BLOOD SUGAR LEVELS. THE CUSTOMER WAS HOSPITALIZED FOR 4 DAYS. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Hypoglycemia

  MAUDE report 9835204 ↗
• MalfunctionOct 29, 2018High Readings; High Readings

  AT 6:58 A.M., THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 315 MG/DL AND 303 MG/DL ON A CONTOUR NEXT ONE METER. AT THE SAME TIME, WHEN TESTED ON A DIFFERENT METER, THE READINGS WERE 74 MG/DL AND 78 MG/DL. THE DIFFERENCES BETWEEN READINGS FALL IN THE "D" ZONE 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 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 8015608 ↗
• MalfunctionOct 29, 2018High Readings; High Readings

  AT 10:23 P.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 320 MG/DL ON A CONTOUR NEXT ONE METER. UPON RETESTING, AT 10:24 P.M. WITH A DIFFERENT METER, A READING OF 77 MG/DL WAS OBTAINED. THE DIFFERENCE BETWEEN READINGS FALL IN THE "D" 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 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 8015606 ↗
• MalfunctionAug 15, 2018High Readings; High Readings

  IN THE EVENING AT 5:44, 7:20 AND 9:25, THE CUSTOMER RECEIVED RESPECTIVE BLOOD GLUCOSE READINGS OF 126, 179 AND 103MG/DL ON THE CONTOUR NEXT LINK 2.4. HER METER PUMP BOLUS OPTION WAS SET UP TO AUTOMATIC, BUT SHE DID NOT RECALL IF SHE RECEIVED ANY ADDITIONAL INSULIN. HER NORMAL DAILY INSULIN DOSAGE IS 42 UNITS. THE CUSTOMER CALLED AN AMBULANCE BECAUSE SHE COULD NOT RESPOND. WHEN THEY ARRIVED AT APPROXIMATELY 10:00PM, SHE WAS NOT TOTALLY AWARE OR RESPONSIVE, AND HAD BLACK OUTS IN BETWEEN QUESTIONS. THE PARAMEDICS TESTED HER BLOOD WITH THEIR METER AND THE READING WAS 17MG/DL. SHE WAS TAKEN TO THE HOSPITAL AND GIVEN IV GLUCOSE. SHE HAD AN MRI TO CHECK BRAIN FUNCTION. FURTHER INFORMATION WAS NOT PROVIDED ABOUT THIS TEST. ONCE SHE WAS ABLE TO RESPOND, SHE WAS GIVEN ORANGE JUICE, AND WAS DISCHARGED AT 4:00AM THE NEXT MORNING. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HER.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7784952 ↗
• MalfunctionAug 10, 2018Unsealed Device Packaging; Unsealed Device Packaging

  A CUSTOMER PURCHASED A BOX OF CONTOUR NEXT TEST STRIPS FROM THE PHARMACY. UPON OPENING THE BOX AT HOME, HE DISCOVERED THE BOTTLE WAS ALREADY OPEN. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR INVESTIGATION REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7773944 ↗
• MalfunctionApr 20, 2018High Readings; High Readings

  THE CUSTOMER HAD INCREASED HER INSULIN DOSAGE FROM 40-50 UNITS A DAY TO 60-70 UNITS A DAY BASED ON READINGS FROM THE CONTOUR NEXT LINK THAT RANGED FROM 155-182MG/DL. AFTER DOING SO, SHE FELT DIZZY AND SHAKY, SO TOOK SOME GLUCOSE TABLETS AND ATE SUGAR, AFTER WHICH, SHE FELT BETTER. PREVIOUSLY, SHE RECEIVED A BLOOD GLUCOSE READING OF 108 ON THE CONTOUR NEXT LINK, RETESTED ON A DIFFERENT METER AND THE READING WAS 65MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THERE WAS NO EVIDENCE OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO HER.

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 7446883 ↗

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-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (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-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-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.