CONTOUR® NEXT 7311Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10301937311502), received between Jun 19, 2017 and Mar 20, 2025 — classified as 21 injuries, 80 malfunctions.

The most frequently reported specific device problem is “High Readings” (60 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Low Readings; Low Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR® NEXT GEN METER AND OBTAINED READINGS OF LO (INDICATIVE OF A READING BELOW 20 MG/DL) AT 9:02 AM AND 9:03 AM, 55 MG/DL AT 9:03 AM, 97 MG/DL AT 9:04 AM, AND ANOTHER LO READING AT 9:08 AM. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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 21652979 ↗
• MalfunctionJan 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED BLOOD GLUCOSE TESTING AND OBTAINED READINGS OF LO (INDICATIVE OF A READING BELOW 10 MG/DL) AT 7:32 A.M. AND 237 MG/DL AT 8:20 A.M. WITH 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. 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 18425922 ↗
• MalfunctionSep 1, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 21 MG/DL AT 12:10 A.M. AND 110 MG/DL AT 12:17 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 17670652 ↗
• InjuryOct 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT METER WERE INACCURATE. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER WAS FEELING SICK AND HAD TO GO TO THE HOSPITAL. NO FURTHER EVENT DETAILS WERE PROVIDED. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 15610371 ↗
• MalfunctionMar 15, 2022Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE ATTEMPTED TO PERFORM BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT LINK 2.4 METER AND RECEIVED ERROR MESSAGES INDICATIVE OF "USED TEST STRIP". THE CUSTOMER THEN PERFORMED REPEAT TESTING AND OBTAINED LO READING, INDICATIVE OF A READING BELOW 20 MG/DL AT 11:02 P.M. AND 97 MG/DL AT 11:03 P.M. 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 13770858 ↗
• MalfunctionJan 12, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 516 MG/DL AT 11:22 A.M., 65 MG/DL AT 11:23 A.M., 180 MG/DL AT 11:27 A.M., AND 105 MG/DL AT 11:29 A.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 13235844 ↗
• MalfunctionNov 10, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 74 MG/DL AT 11:02 P.M. AND 296 MG/DL AT 11:09 P.M. WITH THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER STATED THAT HE TOOK NOVALOG INSULIN BASED ON THE HIGHER READING AND EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA WHICH HE DESCRIBED AS DIZZINESS. THE CUSTOMER TOOK GLUCOSE TABLETS 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: Dizziness; Hypoglycemia

  MAUDE report 12788438 ↗
• MalfunctionSep 7, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 164 MG/DL AT 8:33 A.M., 150 MG/DL AT 8:35 A.M., 153 MG/DL AT 8:35 A.M., AND 22 MG/DL AT 8:43 A.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 12433004 ↗
• MalfunctionSep 1, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 479 MG/DL AT 12:56 P.M., 91 MG/DL AT 12:58 P.M., 78 MG/DL AT 12:58 P.M., AND 81 MG/DL AT 1:00 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 12406539 ↗
• InjuryAug 2, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED HIGH READINGS ON THE CONTOUR NEXT EZ METER WHEN COMPARED WITH THE READING OBTAINED ON THE CONTINUOUS GLUCOSE MONITORING SYSTEM. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER STATED THAT HE WAS HOSPITALIZED DUE TO THE METER READINGS AND RECOVERED WELL. THE CUSTOMER REFUSED TO PROVIDE FURTHER EVENT DETAILS. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12259218 ↗
• MalfunctionJan 27, 2021High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY OBTAINED BLOOD GLUCOSE READINGS OF 245 MG/DL AT 11:26 A.M. ON THE CONTOUR NEXT EZ METER AND 121 MG/DL AT 11:28 A.M. ON THE CONTOUR NEXT 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: Loss of consciousness

  MAUDE report 11235585 ↗
• InjuryJan 14, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 9:27 P.M. HE OBTAINED A BLOOD GLUCOSE READING OF 53 MG/DL ON HIS CONTOUR METER. THE CUSTOMER PERFORMED REPEAT TESTS ON HIS CONTOUR NEXT LINK 2.4 METER AND OBTAINED READINGS OF 345 MG/DL AT 9:50 P.M., 190 MG/DL AT 9:57 P.M., 470 MG/DL AT 9:59 P.M., 47 MG/DL AT 10:18 P.M., AND 38 MG/DL AT 10:22 P.M. AT THIS POINT, THE CUSTOMER WAS NOT PRESENTING ANY SYMPTOMS OF HYPOGLYCEMIA AND TOOK 35 UNITS OF INSULIN. THE CUSTOMER HAD CALLED ASCENSIA DIABETES CARE AT 10:38 P.M., AND DURING THE CALL, THE CUSTOMER FAINTED. DURING THE FOLLOW-UP, THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER RECOVERED AT HOME. NO FURTHER EVENT DETAIL WAS 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 11169305 ↗
• MalfunctionJan 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 48 MG/DL AT 10:44 P.M. AND 289 MG/DL AT 10:53 P.M. ON THE CONTOUR NEXT LINK METER. THE CUSTOMER PERFORMED A REPEAT TESTING WITH THE ALTERNATE CONTOUR NEXT LINK METER AT 10:55 P.M. AND OBTAINED A READING OF 78 MG/DL. 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 11156123 ↗
• MalfunctionJan 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER STATED THAT HE WAS AT THE PHYSICIAN'S OFFICE FOR A REGULAR APPOINTMENT WHERE THEY PERFORMED BLOOD GLUCOSE TESTS AND OBTAINED A DIFFERENCE OF 40 MG/DL BETWEEN THE READINGS OBTAINED ON THE CONTOUR NEXT ONE METER AND AN ALTERNATE METER. NO SPECIFIC READINGS WERE PROVIDED. 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 11116037 ↗
• MalfunctionDec 11, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS WITHIN 10 MINUTES WHICH WERE 40 MG/DL TO 50 MG/DL HIGHER ON THE CONTOUR NEXT LINK 2.4 METER WHEN COMPARED WITH THE CONTOUR NEXT ONE METER. NO SPECIFIC READINGS WERE PROVIDED. THE CUSTOMER TOOK 10 UNITS OF ADDITIONAL HUMALOG INSULIN BASED ON THE HIGHER READING. 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 10992755 ↗
• MalfunctionNov 12, 2020Low Readings; Low Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 518 MG/DL AT 4:21 P.M. AND 160 MG/DL AT 4:22 P.M. ON THE CONTOUR NEXT EZ METER WHILE USING THE CONTOUR NEXT TEST STRIPS FROM LOT # 0APEG18B. ADDITIONALLY, THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF HI (INDICATIVE OF A READING ABOVE 600 MG/DL) AT 5:15 P.M. WITH THE CONTOUR NEXT EZ METER WHILE USING THE CONTOUR NEXT TEST STRIPS FROM LOT # 0APEG18B, AND 214 MG/DL AT 5:16 P.M. AND 247 MG/DL AT 5:17 P.M. ON THE CONTOUR NEXT LINK 2.4 METER WHILE USING THE CONTOUR NEXT TEST STRIPS FROM LOT # 9APEA05A. THE CUSTOMER WAS EXPERIENCING A HEADACHE. HE ATE A FEW BITES OF A LIGHT COOKIE 5 MINUTES BEFORE EATING HIS MEAL. THE CUSTOMER'S HEADACHE SUBSIDED AFTER HE HAD HIS MEAL. 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: Headache

  MAUDE report 10830101 ↗
• MalfunctionOct 14, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 331 MG/DL AT 7:38 A.M. ON THE CONTOUR NEXT ONE METER. WITHIN 10 MINUTES, ANOTHER BLOOD TEST WAS PERFORMED WITH AN ALTERNATE METER AND A READING OF 144 MG/DL WAS OBTAINED. 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 10680238 ↗
• MalfunctionOct 1, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 314 MG/DL AT 12:13 A.M. AND 43 MG/DL AT 12:23 A.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER DID NOT PRESENT ANY SYMPTOMS OF HYPOGLYCEMIA. 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 10612157 ↗
• 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 10566650 ↗
• MalfunctionSep 11, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 8:13 P.M., HE OBTAINED BLOOD GLUCOSE READINGS OF 168 MG/DL AND 81 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER AND CONTOUR NEXT LINK METER RESPECTIVELY. THE CUSTOMER STATED THAT HE WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER TOOK ONE AND ONE-HALF UNITS OF INSULIN BASED ON THE METER'S READINGS AND CONTINUED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KITS WERE SENT TO THE CUSTOMER.

  Patient problems: Hypoglycemia

  MAUDE report 10521705 ↗
• MalfunctionAug 17, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 9:00 A.M., HE OBTAINED BLOOD GLUCOSE READINGS OF 140 MG/DL AND 49 MG/DL ON THE CONTOUR NEXT EZ METER AND NON-ASCENSIA METER RESPECTIVELY. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. 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 10413633 ↗
• MalfunctionAug 17, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 10:02 A.M., HE OBTAINED BLOOD GLUCOSE READINGS OF 68 MG/DL AND 38 MG/DL ON THE CONTOUR NEXT EZ METER AND NON-ASCENSIA METER RESPECTIVELY. THEN, AT 4:58 P.M., THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 122 MG/DL AND 57 MG/DL ON THE CONTOUR NEXT EZ METER AND NON-ASCENSIA METER RESPECTIVELY. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. 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 10413632 ↗
• MalfunctionAug 10, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF 460 MG/DL AT 11:35 P.M. ON THE CONTOUR NEXT LINK 2.4 METER. A REPEAT TESTING WAS PERFORMED ON A NON-ASCENSIA METER AT 11:42 P.M. AND A READING OF 194 MG/DL WAS OBTAINED. 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 Known Impact Or Consequence To Patient

  MAUDE report 10384652 ↗
• InjuryAug 6, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 288 MG/DL AT 1:09 A.M., 301 MG/DL AT 1:20 A.M., 272 MG/DL AT 2:21 A.M., 263 MG/DL AT 2:44 A.M., AND 157 MG/DL AT 8:36 A.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER STATED THAT SHE RECEIVED 2 UNITS OF ADDITIONAL INSULIN FROM THE INSULIN PUMP BASED ON HIGH READINGS. THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA SUCH AS DIZZINESS AND THEN BECAME UNCONSCIOUS. AT 10 A.M., AN AMBULANCE WAS CALLED AND A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE AMBULANCE'S METER, WHICH GAVE A READING OF 32 MG/DL. THE CUSTOMER WAS GIVEN INTRAVENOUS DEXTROSE, 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: Dizziness; Loss of consciousness

  MAUDE report 10372890 ↗
• MalfunctionJul 30, 2020Low Readings; Low Readings

  A DIABETES EDUCATOR CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 234 MG/DL AT 12:23 A.M. AND 207 MG/DL AT 12:24 A.M. ON THE CONTOUR NEXT LINK 2.4 METER. A REPEAT TESTING WAS PERFORMED AT 12:25 A.M. WITH A NON-ASCENSIA METER AND A READING OF 506 MG/DL WAS OBTAINED. 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 10343275 ↗

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-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-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (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-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-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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.