CONTOUR® NEXT 7312Recalls & reported problems

Summary

The FDA's MAUDE database contains 283 adverse event reports that list this exact device (DI 10301937312219), received between Jun 12, 2017 and Sep 25, 2026 — classified as 72 injuries, 211 malfunctions.

The most frequently reported specific device problem is “High Readings” (131 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 25 most recent of 283 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Low Readings

  The customer reported obtaining the following blood glucose results using a Contour® Next Link meter: 151 mg/dL at 5:38 p.m., 150 mg/dL at 5:50 p.m., 130 mg/dL at 6:08 p.m., and 93 mg/dL at 7:00 p.m. The customer also reported obtaining blood glucose results using a Contour® Next One meter of 107 mg/dL at 6:25 p.m., 92 mg/dL at 6:55 p.m., and 129 mg/dL at 7:08 p.m. The customer reported using both Contour® Next Link and Contour® Next One meters with Contour® Next test strips from lots 4JHEG01A and 4KHEG01C. The customer was unable to determine which test strip lot or meter-strip combination was associated with any individual blood glucose result. Based on the reported glucose readings, the customer administered 4 units of insulin. The customer subsequently reported symptoms attributed to hyperglycemia, described as feeling "out of his mind," disoriented, and collapsing. The customer was admitted to a hospital for two days and was treated with insulin and his usual medications. Additional medication details and dosages were not provided. Following treatment, the customer recovered and was discharged from the hospital.The customer was advised to return the device for evaluation.Repla

  Patient problems: Confusion/ Disorientation; Hyperglycemia

  MAUDE report 50898500 ↗
• InjurySep 25, 2026Low Readings

  Patient problems: Confusion/ Disorientation; Hyperglycemia

  MAUDE report 50898428 ↗
• InjuryNov 21, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024, SHE OBTAINED A READING OF 127 MG/DL AT 8:34 P.M. WITH THE CONTOUR NEXT ONE METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA, WHICH SHE DESCRIBED AS SWEATING AND DIZZINESS. THE CUSTOMER WENT TO A HOSPITAL ON (B)(6) 2024 DUE TO PRE-ECLAMPSIA. WHILE IN THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED ON (B)(6) 2024, AND A READING OF 151 MG/DL AT 6:00 P.M. WAS OBTAINED WITH THE PHYSICIAN'S METER, WHILE A READING OF 84 MG/DL WAS OBTAINED AT 6:05 P.M. WITH THE CONTOUR NEXT ONE METER. THE CUSTOMER WAS GIVEN 40 UNITS OF LANTUS AND 30 UNITS OF LISPRO, AFTER WHICH SHE RECOVERED WELL. THE CUSTOMER WAS DISCHARGED ON (B)(6) 2024. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 20746728 ↗
• MalfunctionMar 25, 2024High Readings; High Readings

  THE CUSTOMER REPORTER THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 328 MG/DL AT 7:20 A.M. AND 58 MG/DL AT 7:21 A.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 18967893 ↗
• MalfunctionMar 25, 2024High Readings; High Readings

  THE CUSTOMER REPORTER THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 528 MG/DL AT 8:00 A.M. AND 58 MG/DL AT 7:01 A.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 18967890 ↗
• MalfunctionMar 15, 2024Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT SHE 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 18911144 ↗
• InjuryMar 1, 2024High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 463 MG/DL AT 12:00 A.M. WITH THE CONTOUR NEXT EZ METER. THE CUSTOMER TOOK 40 UNITS OF HUMALOG INSULIN BASED ON THE METER READING AND WENT TO SLEEP BUT DID NOT WAKE UP. THEREFORE, THE ADVOCATE WENT TO THE CUSTOMER'S PLACE AND UPON THEIR ARRIVAL FOUND THE CUSTOMER TO BE INCOHERENT. THE ADVOCATE PERFORMED TESTING WITH THE CUSTOMER'S CONTOUR NEXT EZ METER AND OBTAINED A READING OF 41 MG/DL AT 3:19 P.M. THE ADVOCATE THEN CALLED AN AMBULANCE WHO PERFORMED A BLOOD TEST WITH THEIR METER AND OBTAINED A READING OF 121 MG/DL AT 3:27 P.M. A REPEAT TESTING WAS PERFORMED WITH THE CONTOUR NEXT EZ METER AND A READING OF 282 MG/DL WAS OBTAINED AT 3:27 P.M. THE CUSTOMER WAS GIVEN GLUCOSE SOLUTION AFTER WHICH THEY RECOVERED WELL. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Loss of consciousness

  MAUDE report 18813794 ↗
• MalfunctionMar 1, 2024High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE TOOK MORE THAN NORMAL INSULIN BASED ON THE HIGH READING OBTAINED WITH HER CONTOUR NEXT ONE METER. NO SPECIFIC READING WAS PROVIDED. THE CUSTOMER WAS FEELING UNWELL. SHE STATED THAT SHE WAS VOMITING AND HAVING A SEIZURE. THE CUSTOMER WAS HOSPITALIZED FOR TWO DAYS WHERE SHE WAS TREATED. THE CUSTOMER RECOVERED WELL, HOWEVER, SHE IS STILL USING THE MEDICATION FOR SEIZURE. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Convulsion/Seizure; Vomiting

  MAUDE report 18813789 ↗
• MalfunctionFeb 6, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT WHILE USING THE CONTOUR NEXT GEN METER, SHE OBTAINED BLOOD GLUCOSE READINGS OF LO (INDICATIVE OF A READING BELOW 10 MG/DL) AT 10:37 A.M. WITH THE FIRST VIAL OF THE CONTOUR NEXT TEST STRIPS AND 129 MG/DL AT 10:37 A.M. WITH THE SECOND VIAL OF THE CONTOUR NEXT TEST STRIPS FROM THE SAME LOT # AS THE FIRST VIAL. 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 18650165 ↗
• MalfunctionNov 13, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 25 MG/DL AT 12:42 P.M. AND 113 MG/DL AT 12:43 P.M. WITH THE CONTOUR NEXT EZ 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 18118950 ↗
• MalfunctionNov 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WITHIN 10 MINUTES, SHE OBTAINED BLOOD GLUCOSE READINGS OF 67 MG/DL, 244 MG/DL AND 244 MG/DL WITH THE CONTOUR NEXT EZ 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 18118948 ↗
• MalfunctionAug 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 300 MG/DL AT 3:48 P.M., 172 MG/DL AT 3:49 P.M. AND 60 MG/DL AT 3:51 P.M. WITH THE CONTOUR NEXT EZ 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 17595273 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT GEN METER AND OBTAINED READINGS OF 126 MG/DL AT 6:24 A.M. AND 129 MG/DL AT 8:21 A.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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390872 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 132 MG/DL AT 8:06 A.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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390869 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 94 MG/DL AT 6:30 A.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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390859 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 147 MG/DL AT 9:11 A.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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390857 ↗
• InjuryJun 16, 2023High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED HIGH BLOOD GLUCOSE READINGS WITH THE CONTOUR NEXT EZ METER. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA WHICH WERE DESCRIBED AS FEELING DIZZY AND NAUSEOUS. THE CUSTOMER WAS HOSPITALIZED FOR FOUR DAYS WHERE HER BLOOD GLUCOSE LEVELS WERE CONSTANTLY MONITORED. SHE WAS GIVEN MEDICATION TO REGULATE HER BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ALSO PRESCRIBED FAST-ACTING INSULIN, AT LEAST 1 INJECTION IN CASE THE METER DISPLAYED HIGH READINGS AFTER EATING. THE CUSTOMER RECOVERED WELL AFTER TREATMENT. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Dizziness; Nausea

  MAUDE report 17142883 ↗
• MalfunctionJun 5, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 25 MG/DL AT 9:42 A.M., 202 MG/DL AT 9:44 A.M. AND 205 MG/DL AT 9:48 A.M. WITH 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 17059022 ↗
• InjuryMay 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT AT 4:00 A.M. SHE RECEIVED INSULIN FROM HER INSULIN PUMP BASED ON THE READING OBTAINED ON THE CONTOUR NEXT LINK 2.4 METER. NO SPECIFIC READING WAS PROVIDED. THE CUSTOMER FAINTED AFTER ADMINISTERING INSULIN. SHE TOOK GLUCOSE TABLETS TO REGULATE HER SUGAR LEVEL AND RECOVERED WELL. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Syncope/Fainting

  MAUDE report 16853150 ↗
• InjuryApr 18, 2023High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 180 MG/DL AT 7:19 A.M. WITH THE CONTOUR NEXT GEN METER. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA WHICH SHE DESCRIBED AS FEELING DIZZY. THE CUSTOMER WENT TO THE HOSPITAL WHERE A BLOOD GLUCOSE TEST WAS PERFORMED AND A READING OF 40 MG/DL WAS OBTAINED. THE CUSTOMER WAS GIVEN INTRAVENOUS MEDICATION AT 11:00 A.M. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 16761531 ↗
• MalfunctionApr 13, 2023High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 363 MG/DL AND 89 MG/DL AT 1:00 P.M. WITH THE CONTOUR NEXT EZ METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA WHICH SHE DESCRIBED AS FEELING WARM AND COULD PASS OUT. THE CUSTOMER TOOK RELION GLUCOSE TABLETS AND APPLE JUICE AND RECOVERED WELL. 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: Hypoglycemia

  MAUDE report 16735686 ↗
• InjuryApr 3, 2023Low Readings; Low Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 407 MG/DL AND 360 MG/DL WITH THE CONTOUR NEXT LINK 2.4 METER. BASED ON THOSE READINGS, THE CUSTOMER RECEIVED 8 UNITS AND 6.4 UNITS OF INSULIN RESPECTIVELY FROM THE INSULIN PUMP. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA, WHICH WERE DESCRIBED AS HEADACHE, NAUSEA AND TIGHT CHEST. THE CUSTOMER WAS HOSPITALIZED AND INSULIN WAS CHANGED AS A TREATMENT. A LABORATORY TESTING WAS PERFORMED IN THE HOSPITAL AND A READING OF 306 MG/DL WAS RECEIVED. THE CUSTOMER RECOVERED WELL AND WAS DISCHARGED AFTER 3 DAYS OF HOSPITALIZATION. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Headache; Hyperglycemia; Nausea

  MAUDE report 16663587 ↗
• MalfunctionFeb 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 89 MG/DL AT 7:11 P.M., 53 MG/DL AT 7:14 P.M. AND 330 MG/DL AT 7:16 P.M. WITH THE CONTOUR NEXT LINK 2.4 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 16436019 ↗
• InjuryDec 1, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 159 MG/DL AT 5:38 A.M. WITH THE CONTOUR NEXT LINK METER. BASED ON THE METER READINGS, THE CUSTOMER RECEIVED HUMALOG FROM AN INSULIN PUMP. THE CUSTOMER THEN EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA WHICH SHE DESCRIBED AS BRAIN NOT FUNCTIONING PROPERLY AND BEING SHAKY, HUNGRY AND SLEEPY. THE CUSTOMER WENT TO THE HOSPITAL WHERE SHE RECEIVED JUICE AND FOOD TO REHYDRATE HER. THE CUSTOMER RECOVERED WELL AFTER THE TREATMENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 15894553 ↗
• InjuryOct 14, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT LINK 2.4 METER AND THE READING OBTAINED ON THE METER WAS HIGHER THAN THAT ON THE INSULIN PUMP. NO SPECIFIC READINGS WERE PROVIDED. THE INSULIN PUMP DELIVERED INSULIN BASED ON THE INCORRECT READING AND THE CUSTOMER FAINTED. THE CUSTOMER STATED THAT THE EVENT OCCURRED THREE TIMES AND EVERY TIME HE HAD TO CALL AN EMERGENCY SERVICE. THE CUSTOMER STATED THAT THE PHYSICIAN ADJUSTED THE INSULIN PUMP TO DELIVER RIGHT AMOUNT OF INSULIN. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Syncope/Fainting

  MAUDE report 15611141 ↗

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-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• 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-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-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-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-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-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-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.