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CONTOUR® NEXT 7308Recalls & reported problems

Ascensia Diabetes Care US Inc. · Blood Glucose Test Strips - 50 Test Strips. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This CONTOUR NEXT blood glucose test strip device has 93 adverse event reports naming it: 70 malfunctions and 23 injuries, with no deaths. Reports mostly describe high, low, or imprecise glucose readings, sometimes with unsealed packaging, and some mention hypoglycemia or dizziness. There are no recalls naming this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
93
Deaths reported
0
Injuries reported
23
Recalls naming it
0

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10301937308502), received between Jun 29, 2017 and Feb 6, 2024 — classified as 23 injuries, 70 malfunctions.

The most frequently reported specific device problem is “High Readings” (47 reports).

22 other recalls cover devices cleared under the same FDA submission (K121190, K160430, K162336, 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • High Readings47
  • Incorrect, Inadequate or Imprecise Result or Readings25
  • Low Readings12
  • Unsealed Device Packaging3
  • Missing Information2
  • Appropriate Device Problem Term/Code Not Available1
  • Device Contamination with Chemical or Other Material1
  • Device Operates Differently Than Expected1

Patient problems

  • No Known Impact Or Consequence To Patient48
  • Hypoglycemia13
  • Dizziness10
  • Loss of consciousness9
  • No Clinical Signs, Symptoms or Conditions9
  • Sweating8
  • Shaking/Tremors7
  • Weakness6

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 240 MG/DL AT 3:46 P.M., 361 MG/DL AT 3:50 P.M. AND 102 MG/DL AT 3:52 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 18650167 ↗
  • InjuryAug 4, 2023High Readings; High Readings

    THE CUSTOMER REPORTED THAT SHE OBTAINED HIGH BLOOD GLUCOSE READINGS WITH THE CONTOUR NEXT ONE METER. NO SPECIFIC READING ASSOCIATED WITH THE EVENT WAS PROVIDED. HOWEVER, THE CUSTOMER STATED THAT SHE OBTAINED READINGS OF 35 MG/DL AT 3:32 P.M., 182 MG/DL AT 3:47 P.M. AND 85 MG/DL AT 4:11 P.M. THE CUSTOMER TOOK INSULIN BASED ON THE HIGH READING AND EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER HAD TO CALL AN AMBULANCE. SHE RECEIVED GLUCOSE FROM THE PARAMEDICS 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: Hypoglycemia

    MAUDE report 17460190 ↗
  • MalfunctionOct 18, 2021High Readings; High Readings

    THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 381 MG/DL AT 7:09 A.M. AND 99 MG/DL AT 7:10 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 12647306 ↗
  • MalfunctionOct 6, 2021Unsealed Device Packaging; Unsealed Device Packaging

    THE CUSTOMER REPORTED THAT SHE RECEIVED TWO BOTTLES OF THE CONTOUR NEXT TEST STRIPS FROM (B)(6) WHICH WERE ALREADY OPEN. ONE OF THE TWO BOTTLES HAD THE HINGE OF THE CAP BROKEN AND OFF THE VIAL. 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 12582900 ↗
  • MalfunctionAug 6, 2021Inaccurate Information; Inaccurate Information

    THE CUSTOMER REPORTED THAT THEY PURCHASED A BOTTLE OF THE CONTOUR NEXT TEST STRIPS FROM (B)(6), WHICH WAS RELABELED. THE LABELING INFORMATION PRINTED BY ASCENSIA ON THE BOTTLE OF CONTOUR NEXT TEST STRIPS AND CARTON DISPLAYED THE LOT # AS 1APEG06A AND EXPIRATION DATE AS 31-JAN-2023, WHICH IS THE CORRECT LABELING INFORMATION. HOWEVER, THE CARTON OF THE CONTOUR NEXT TEST STRIPS WAS RELABELED WITH A STICKER DISPLAYING THE LOT # AS 1BPEH02A AND EXPIRATION DATE AS 28-FEB-2023. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12287995 ↗
  • MalfunctionAug 2, 2021High Readings; High Readings

    THE CUSTOMER REPORTED THAT WITHIN 10 MINUTES SHE OBTAINED BLOOD GLUCOSE READINGS OF HI (INDICATIVE OF READING ABOVE 600 MG/DL), 109 MG/DL, 172 MG/DL, 143 MG/DL, 146 MG/DL, 201 MG/DL, AND 131 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 12259197 ↗
  • InjuryApr 7, 2021High Readings; High Readings

    THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 248 MG/DL AT 8:30 P.M. ON THE CONTOUR NEXT LINK METER. THE CUSTOMER RECEIVED LONG ACTING INSULIN FROM HER INSULIN PUMP BASED ON THIS READING AND STARTED EXPERIENCING SYMPTOMS SUCH AS HEADACHE, DIZZINESS AND BLURRED VISION. THE CUSTOMER STATED THAT SHE BECAME UNCONSCIOUS. THE CUSTOMER HAD NOT SOUGHT MEDICAL ATTENTION. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER DECLINED TO RETURN THE DEVICE FOR EVALUATION. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Patient problems: Blurred Vision; Dizziness; Headache; Loss of consciousness

    MAUDE report 11628651 ↗
  • MalfunctionFeb 17, 2021Low Readings; Low Readings

    THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 38 MG/DL AT 2:59 P.M., 222 MG/DL AT 3:04 P.M., 202 MG/DL AT 3:05 P.M., AND 216 MG/DL AT 3:06 P.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER DID NOT EXPERIENCE ANY 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: Hypoglycemia

    MAUDE report 11338215 ↗
  • MalfunctionFeb 12, 2021Missing Information; Missing Information

    THE CUSTOMER ALLEGED THAT THERE WAS NO LABELING INFORMATION (LOT #, EXPIRATION DATE AND CONTROL RANGES) ON THE BOTTLE OF THE CONTOUR NEXT TEST STRIPS. 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 11320787 ↗
  • MalfunctionJan 12, 2021High Readings; High Readings

    THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 500 MG/DL AT 1:23 P.M. AND 124 MG/DL AT 1:27 P.M. ON THE CONTOUR NEXT EZ 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 11156126 ↗
  • MalfunctionNov 12, 2020Unsealed Device Packaging; Unsealed Device Packaging

    THE CUSTOMER REPORTED THAT THE BOX AND BOTTLE OF CONTOUR NEXT TEST STRIPS WERE CRUSHED AND ALREADY OPEN. THE CUSTOMER ALSO STATED THAT THERE WERE ONLY 30 TEST STRIPS IN THE BOTTLE WHICH SHOULD HAVE 50 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 10830081 ↗
  • MalfunctionNov 3, 2020Low Readings; Low Readings

    THE CUSTOMER REPORTED THAT WITHIN 10 MINUTES, SHE OBTAINED A BLOOD GLUCOSE READING OF 60 MG/DL ON THE CONTOUR NEXT EZ METER AND 268 MG/DL ON A DIFFERENT METER. 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10777687 ↗
  • MalfunctionOct 7, 2020Low Readings; Low Readings

    THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 387 MG/DL AND 38 MG/DL AT 4:28 A.M. ON THE CONTOUR NEXT ONE METER. THE CUSTOMER EXPERIENCED A SYMPTOM OF HYPERGLYCEMIA I.E. FREQUENT URINATION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Patient problems: Hyperglycemia

    MAUDE report 10643005 ↗
  • MalfunctionAug 24, 2020High Readings; High Readings

    THE CUSTOMER REPORTED THAT HE WAS ADMITTED TO THE HOSPITAL FOR A SURGERY, AN EVENT UNRELATED TO DIABETES. THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 93 MG/DL AT 1:59 A.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER TOOK INSULIN FROM THE INSULIN PUMP BASED ON THE METER READING. A LABORATORY TESTING WAS PERFORMED AT 2:09 A.M. AND A READING OF 57 MG/DL WAS OBTAINED. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS SWEATING. THE CUSTOMER WAS GIVEN CRACKERS AND COOKIES TO INCREASE HIS BLOOD GLUCOSE LEVELS. ADDITIONALLY, THE CUSTOMER STATED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 126 MG/DL WITH THE CONTOUR NEXT LINK 2.4 METER AND 50 MG/DL OR 60 MG/DL WITH THE LABORATORY TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Patient problems: Sweating

    MAUDE report 10443034 ↗
  • 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 10361524 ↗
  • InjuryJun 5, 2020High Readings; High Readings

    AN ADVOCATE REPORTED THAT CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 55 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS WEAKNESS AND SHE WAS FEELING SLEEPY. THE ADVOCATE GAVE 3 GLUCOSE TABLETS AND A GLASS OF MILK TO THE CUSTOMER. ADDITIONAL TESTING WAS PERFORMED WITH THE CONTOUR NEXT LINK 2.4 METER AND READINGS OF 66 MG/DL AND 61 MG/DL WERE OBTAINED. ANOTHER TESTING WAS PERFORMED WITH THE SECOND CONTOUR NEXT LINK 2.4 METER AND A READING OF 183 MG/DL WAS OBTAINED. ALL READINGS WERE OBTAINED WITHIN 10 MINUTES. THE CUSTOMER FELT BETTER AFTER ADMINISTERING GLUCOSE TABLETS AND DRINKING MILK. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Patient problems: Hypoglycemia; Weakness

    MAUDE report 10122922 ↗
  • MalfunctionMay 27, 2020High Readings; High Readings

    THE CUSTOMER REPORTED THAT HE TOOK METFORMIN AND LATER PERFORMED BLOOD GLUCOSE TESTS ON HIS CONTOUR NEXT EZ METER AND OBTAINED READINGS OF 361 MG/DL AT 7:02 A.M. AND 146 MG/DL AT 7:05 A.M. ANOTHER TESTING WAS PERFORMED ON A DIFFERENT METER AT 7:05 A.M. AND A READING OF 120 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 10091891 ↗
  • MalfunctionMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT SHE OBTAINED A DIFFERENCE OF 40-60 MG/DL BETWEEN BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT EZ METER AND A DIFFERENT 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 Known Impact Or Consequence To Patient

    MAUDE report 10055359 ↗
  • MalfunctionMay 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    A NURSE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 69 MG/DL AND 157 MG/DL ON TWO SEPARATE CONTOUR NEXT EZ METERS. 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; Shaking/Tremors; Weakness

    MAUDE report 10016795 ↗
  • MalfunctionApr 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT SHE PERFORMED A BLOOD GLUCOSE TEST AND OBTAINED A READING OF 53 MG/DL ON THE CONTOUR NEXT ONE 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. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9977164 ↗
  • MalfunctionApr 14, 2020Missing Information; Missing Information

    THE CUSTOMER REPORTED THAT THE LOT NUMBER, EXPIRATION DATE AND CONTROL RANGES WERE NOT PRINTED ON THE BOTTLE OF CONTOUR NEXT TEST STRIPS. THE CUSTOMER DID NOT USE THE TEST STRIPS FOR TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCARDED THE TEST STRIPS, THEREFORE, THE DEVICE 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 9956916 ↗
  • MalfunctionMar 4, 2020High Readings; High Readings

    AN ADVOCATE REPORTED THAT THE CUSTOMER PERFORMED COMPARISON OF BLOOD GLUCOSE TESTING WITH THEIR CONTOUR NEXT EZ METER AND SCHOOL METER AND OBTAINED READINGS OF 534 MG/DL AND 134 MG/DL RESPECTIVELY. BOTH READINGS WERE OBTAINED WITHIN FIVE MINUTES. THE CUSTOMER DID NOT HAVE SYMPTOMS OF HYPERGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE ADVOCATE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9787321 ↗
  • MalfunctionFeb 14, 2020Unsealed Device Packaging; Unsealed Device Packaging

    THE CUSTOMER OPENED A BOX OF 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 TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9712546 ↗
  • MalfunctionJan 28, 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 20 MG/DL AT 1:06 P.M. ON THE CONTOUR NEXT LINK METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER PERFORMED ANOTHER TESTING ON THE CONTOUR NEXT ONE METER AND OBTAINED A READING OF 92 MG/DL AT 1:15 P.M. THE CUSTOMER THEN PERFORMED A REPEAT TESTING ON THE CONTOUR NEXT LINK METER AND OBTAINED A READING OF 166 MG/DL AT 1:18 P.M. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9638145 ↗
  • InjuryNov 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    AN ADVOCATE REPORTED THAT THE CUSTOMER (HIS SON) TOOK 6 UNITS OF INSULIN IN THE MORNING, WHICH WAS HIS USUAL DOSAGE. AFTERWARDS, BLOOD GLUCOSE TESTING WAS PERFORMED WITH THE CUSTOMER'S CONTOUR NEXT EZ METER AND FOLLOWING READINGS WERE OBTAINED WITHIN THE TIMEFRAME OF 10 MINUTES: 46 MG/DL, 83 MG/DL, 44 MG/DL, 94 MG/DL, AND 99 MG/DL. THE CUSTOMER WAS FEELING DIZZY. ADVOCATE GAVE HIM TWO CRACKERS WHEN THE READING OF 46 MG/DL WAS OBTAINED. ADVOCATE STATED THAT AFTER 6 MINUTES, THE READING WAS STILL 44 MG/DL, SO HE GAVE HIM TWO MORE CRACKERS. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER KITS WERE SENT TO THE CUSTOMER.

    Patient problems: Dizziness

    MAUDE report 9340656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121190, K160430, K162336, 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-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-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-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
  • 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 7 more.

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Sources and updates

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