CONTOUR® 7080GRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10301937080507), received between Jun 7, 2017 and May 1, 2025 — classified as 19 injuries, 42 malfunctions.

The most frequently reported specific device problem is “High Readings” (21 reports).

2 other recalls cover devices cleared under the same FDA submission (K062058); 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT SHE OPENED A BOX OF THE CONTOUR® 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942048 ↗
• MalfunctionAug 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD GLUCOSE TEST WITH THE CONTOUR METER AND OBTAINED A READING OF 61 MG/DL AT 7:48 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 17460188 ↗
• MalfunctionAug 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD GLUCOSE TEST WITH THE CONTOUR METER AND OBTAINED A READING OF 130 MG/DL AT 1:21 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460186 ↗
• MalfunctionMay 18, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT AT 8:15 A.M., SHE OBTAINED BLOOD GLUCOSE READINGS OF 24 MG/DL AND 115 MG/DL ON THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841273 ↗
• MalfunctionMar 30, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 541 MG/DL AT 3:35 P.M., 338 MG/DL AT 3:36 P.M., 449 MG/DL AT 3:37 P.M., AND 123 MG/DL AT 3:43 P.M. ON THE CONTOUR 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 11588642 ↗
• InjuryFeb 3, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 12:00 A.M. HE OBTAINED A BLOOD GLUCOSE READING OF 374 MG/DL WITH HIS CONTOUR METER. THE CUSTOMER STATED THAT HE DID NOT EAT ANYTHING FOR 7 HOURS PRIOR TO THE EVENT. THE CUSTOMER TOOK 3 UNITS OF LONG-LASTING INSULIN BASED ON THE READING OF 374 MG/DL. DURING THE NIGHT AFTER ADMINISTERING INSULIN, THE CUSTOMER PASSED OUT. THE CUSTOMER'S FAMILY MEMBER GAVE HIM SODA AFTER WHICH HE RECOVERED WELL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Loss of consciousness

  MAUDE report 11273737 ↗
• MalfunctionFeb 2, 2021High Readings; High Readings

  THE CUSTOMER CALLED TO REPORT THAT WITHIN 10 MINUTES, HE OBTAINED BLOOD GLUCOSE READINGS OF 388 MG/DL ON THE CONTOUR METER AND 174 MG/DL ON A NON-ASCENSIA METER. 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 11268117 ↗
• MalfunctionJan 7, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A COMPARISON OF BLOOD GLUCOSE TESTS WITH THE CONTOUR AND CONTOUR NEXT METERS AND OBTAINED READINGS OF 440 MG/DL AND 140 MG/DL RESPECTIVELY. ANOTHER COMPARISON WAS PERFORMED AND THE READINGS OBTAINED WERE 472 MG/DL AND 140 MG/DL RESPECTIVELY. 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 11132701 ↗
• MalfunctionJan 2, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 81 MG/DL AT 9:28 A.M. AND 17 MG/DL AT 9:29 A.M. ON THE CONTOUR METER. THE CUSTOMER DID NOT PRESENT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103603 ↗
• MalfunctionJan 2, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT AT 8:29 A.M., SHE OBTAINED BLOOD GLUCOSE READINGS OF 13 MG/DL AND 132 MG/DL ON THE CONTOUR METER. THE CUSTOMER DID NOT PRESENT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103601 ↗
• MalfunctionDec 2, 2020Unsealed Device Packaging; Unsealed Device Packaging

  A PHARMACIST CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY OPENED A BOX OF CONTOUR TEST STRIPS AND THE BOTTLE WAS ALREADY OPEN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PHARMACIST WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE PHARMACIST, WHO HAD REPLACED THE TEST STRIPS FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936631 ↗
• MalfunctionNov 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WITHIN ONE MINUTE, HE OBTAINED BLOOD GLUCOSE READINGS OF 300 MG/DL AND 17 MG//DL ON THE CONTOUR METER. IT IS UNKNOWN IF THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA DURING THIS EVENT. NO FURTHER EVENT DETAILS WERE PROVIDED. 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 10854021 ↗
• MalfunctionOct 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE CALLED ON BEHALF OF HER FATHER TO REPORT THAT THEY OBTAINED A DIFFERENCE OF MORE THAN 40 MG/DL BETWEEN BLOOD GLUCOSE READINGS RECEIVED ON THE CONTOUR METER. NO SPECIFIC READINGS WERE PROVIDED. 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 10719194 ↗
• MalfunctionOct 22, 2020Low Readings; Low Readings

  AN ADVOCATE REPORTED THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READING OF 14 MG/DL AT 8:27 A.M., AND 110 MG/DL AT 8:29 A.M. ON THE CONTOUR METER. THE CUSTOMER DID NOT PRESENTED SYMPTOMS OF HYPOGLYCEMIA. 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 10719182 ↗
• MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 120 MG/DL AT 8:55 P.M. AND 128 MG/DL AT 9:00 P.M. THE METER AUTOMATICALLY MARKED THEM AS CONTROL TESTS, SO THE READINGS WILL BE DISPLAYED AS A 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 10547860 ↗
• MalfunctionSep 8, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT WITHIN 2 MINUTES, SHE OBTAINED BLOOD GLUCOSE READINGS OF 559 MG/DL ON THE CONTOUR METER AND 136 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. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10503432 ↗
• MalfunctionAug 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 182 MG/DL AND 73 MG/DL AT 9:30 A.M. ON TWO SEPARATE CONTOUR METERS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KITS AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384644 ↗
• MalfunctionAug 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 310 MG/DL AND 88 MG/DL AT 9:30 A.M. ON TWO SEPARATE CONTOUR METERS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KITS AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384642 ↗
• MalfunctionJul 28, 2020Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT THE BOTTLE OF CONTOUR TEST STRIPS WAS NOT SEALED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10332142 ↗
• InjuryJul 6, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 264 MG/DL AT 10:41 P.M. ON THE CONTOUR METER. BASED ON THE HIGH READING, THE CUSTOMER TOOK 5 ADDITIONAL UNITS OF NOVALOG INSULIN. THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA SUCH AS CONFUSION, DIZZINESS, SWEATING, AND SHAKINESS. THE CUSTOMER CALLED EMERGENCY SERVICES. UPON THEIR ARRIVAL, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS TESTED WITH HER METER AND A READING OF 35 MG/DL WAS OBTAINED AT 2:55 A.M. THE PARAMEDICS GAVE HER ORAL GLUCOSE, 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: Confusion/ Disorientation; Dizziness; Shaking/Tremors; Sweating

  MAUDE report 10233920 ↗
• MalfunctionJul 1, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED COMPARISON TESTING BETWEEN HIS CONTOUR METER AND CONTOUR NEXT METER. WITHIN 3 MINUTES, THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 157 MG/DL ON THE CONTOUR METER AND 355 MG/DL 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 Known Impact Or Consequence To Patient

  MAUDE report 10219559 ↗
• MalfunctionMay 22, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE TOOK 25 UNITS OF INSULIN AT 2:25 A.M. AT 5:48 A.M., THE CUSTOMER PERFORMED A BLOOD GLUCOSE TEST AND OBTAINED A HI READING (INDICATIVE OF A READING ABOVE 600 MG/DL) ON THE CONTOUR METER. WITHIN 5 MINUTES, THE CUSTOMER OBTAINED A READING OF 77 MG/DL ON ANOTHER METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. 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 10083020 ↗
• MalfunctionJan 7, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE WENT TO AN EMERGENCY ROOM AS SHE WAS RECEIVING HIGH READING ON HER CONTOUR USB METER. WHILE IN THE EMERGENCY ROOM, SHE OBTAINED A READING OF 400 MG/DL ON THE CONTOUR USB METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. WITHIN A MINUTE, THE NURSE PERFORMED A REPEAT TESTING WITH THE HOSPITAL'S METER AND OBTAINED A READING OF 195 MG/DL. 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 9558539 ↗
• MalfunctionNov 19, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE VISITED HIS PHYSICIAN FOR REGULAR APPOINTMENT. WHILE AT THE PHYSICIAN'S OFFICE, THE CUSTOMER MEASURED HIS BLOOD GLUCOSE READING WITH THE PHYSICIAN'S METER AT 8:45 A.M. AND OBTAINED A READING OF 269 MG/DL. HE THEN PERFORMED A REPEAT TESTING WITH HIS CONTOUR METER AT 8:46 A.M. AND OBTAINED A READING OF 111 MG/DL. THERE WAS NO ALLEGATION OF ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9340655 ↗
• InjuryOct 11, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING DISPLAYED AS HI ON HER CONTOUR METER, WHICH IS INDICATIVE OF READING ABOVE 600 MG/DL. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. HOWEVER, SHE TOOK 20 UNITS OF NOVOLOG INSULIN, AFTER WHICH SHE PASSED OUT. AN AMBULANCE WAS CALLED AND SHE WAS TREATED BY THE PARAMEDICS. NO TREATMENT DETAILS WERE PROVIDED. WHEN THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST ON THEIR METER, THEY OBTAINED A READING OF 40 MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED. NO TREATMENT DETAILS WERE PROVIDED. THE CUSTOMER WAS IN THE HOSPITAL FOR 3 DAYS. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Loss of consciousness

  MAUDE report 9178002 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062058. One submission often covers many models, so check the product and lot details in each record.

• Z-3268-2011 · Aug 12, 2011 · Terminated
  Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in w
• Z-1001-2007 · Jun 6, 2007 · Terminated
  Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.