CONTOUR® 7097CRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10301937097505), received between Jun 22, 2017 and Aug 1, 2022 — classified as 2 injuries, 13 malfunctions.

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

• MalfunctionAug 1, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 357 MG/DL AT 9:27 A.M. AND 83 MG/DL AT 9:29 A.M. WITH 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 15138968 ↗
• MalfunctionJul 1, 2020Missing Information; Missing Information

  THE CUSTOMER REPORTED THAT THE LOT NUMBER AND EXPIRATION DATE WERE MISSING FROM THE LABEL OF TWO OF THEIR CONTOUR TEST STRIPS VIALS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10219583 ↗
• MalfunctionFeb 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT AT 12:14 A.M. SHE OBTAINED A BLOOD GLUCOSE READING OF 90 MG/DL ON THE CONTOUR METER. AT 12:15 A.M., SHE PERFORMED REPEAT TESTING ON THE CONTOUR METER AND ON AN ALTERNATE CONTOUR METER OBTAINING READINGS OF 89 MG/DL AND 167 MG/DL RESPECTIVELY. 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 9731882 ↗
• InjuryDec 17, 2019High Readings; High Readings

  AN ADVOCATE CALLED TO REPORT THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 140 MG/DL WHILE USING THE CONTOUR METER AND 92 MG/DL WITH LABORATORY TESTING. BOTH READINGS WERE OBTAINED AT THE SAME TIME. THE CUSTOMER WAS EXPERIENCING SYMPTOMS SUCH AS HEADACHE AND DIZZINESS. THE CUSTOMER ADJUSTED HER DIET BASED ON THE METER READINGS BY REPLACING CARBOHYDRATES WITH VEGETABLES AND FELT UNWELL. NEXT DAY, THE CUSTOMER PASSED OUT. SHE WAS HOSPITALIZED AND RECEIVED MEDICAL ATTENTION. NO FURTHER DETAILS WERE PROVIDED. THE ADVOCATE WAS ADVISED TO RETURN THE TESTS STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Dizziness; Headache; Loss of consciousness

  MAUDE report 9481712 ↗
• MalfunctionJun 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AT 5:56 P.M., THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 13 MG/DL AND 159 MG/DL ON A CONTOUR METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THAT SHE USED ALL THE TEST STRIPS FROM THE AFFECTED LOT, THEREFORE, THE TEST STRIPS ARE NOT EXPECTED TO BE RETURNED. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730459 ↗
• MalfunctionJan 16, 2019High Readings; High Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT BLOOD GLUCOSE READINGS OF 350 MG/DL AND 450 MG/DL WERE OBTAINED FOR TWO SEPARATE PATIENTS ON A CONTOUR METER. UPON RETESTING WITH A DIFFERENT METER, A READING OF 150 MG/DL WAS OBTAINED FOR BOTH PATIENTS. THE DIFFERENCES BETWEEN THE READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WERE ALLEGED. THE HCP WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER, TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253204 ↗
• MalfunctionJan 16, 2019High Readings; High Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT BLOOD GLUCOSE READINGS OF 350 MG/DL AND 550 MG/DL WERE OBTAINED FOR TWO SEPARATE PATIENTS ON A CONTOUR METER. UPON RETESTING WITH A DIFFERENT METER, READINGS OF 97 MG/DL AND 120 MG/DL RESPECTIVELY WERE OBTAINED. THE DIFFERENCES BETWEEN THE READINGS FALLS IN "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WERE ALLEGED. THE HCP WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER, TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253202 ↗
• MalfunctionJan 16, 2019High Readings; High Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A BLOOD GLUCOSE READING OF "HI" (INDICATIVE OF ABOVE ASSAY RANGE) WAS OBTAINED ON A CONTOUR METER. UPON RETESTING WITH A DIFFERENT METER, A READING OF 250 MG/DL WAS OBTAINED. THE DIFFERENCE BETWEEN THE READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE HCP WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER, TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253201 ↗
• MalfunctionNov 14, 2018Low Readings; Low Readings

  THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 41 MG/DL ON A CONTOUR METER. UPON RETESTING ON A DIFFERENT METER, A READING OF 146 MG/DL WAS OBTAINED. THE CUSTOMER DID NOT FEEL ANY SYMPTOMS. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. 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 8068591 ↗
• MalfunctionOct 16, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER'S CAREGIVER REPORTED, AT 11:20 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 127 MG/DL ON A CONTOUR METER. UPON RETESTING, AT 11:22 A.M. ON TWO DIFFERENT CONTOUR METERS, THE READINGS OF 271 MG/DL AND 341 MG/DL WERE OBTAINED. THE DIFFERENCES BETWEEN THE READINGS FALLS IN ZONE "C" OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER, TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7968689 ↗
• MalfunctionMar 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RAN A BLOOD TEST ON THE CONTOUR. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW STRIPS AND METER WERE SENT TO HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7369868 ↗
• MalfunctionJan 8, 2018High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 188MG/DL ON THE CONTOUR, RETESTED ON A DIFFERENT METER AND THE READING WAS 78MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7171411 ↗
• MalfunctionOct 6, 2017High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF HI ON THE CONTOUR METER, RETESTED ON A DIFFERENT METER AND THE READING WAS 140MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND NEW METER WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6921615 ↗
• InjuryJul 17, 2017High Readings; High Readings

  AT 3:54PM THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 335MG/DL ON THE CONTOUR. HE WAS NOT SYMPTOMATIC FOR HYPERGLYCEMIA BUT TOOK 44 UNITS OF INSULIN. AT 4:54PM HE STOPPED BY THE NURSE'S OFFICE TO HAVE A BLOOD TEST. THE READING WAS 30MG/DL AND THE CUSTOMER WAS SWEATING. HE RAN ANOTHER TEST ON HIS METER AND RECEIVED 225MG/DL. HE WAS GIVEN (B)(6) TO DRINK BECAUSE OF THE LOW READING, AND AT 5:24PM HE RAN A TEST ON THE CONTOUR AND RECEIVED A READING OF 151MG/DL THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HIM.

  Patient problems: Sweating

  MAUDE report 6719862 ↗
• MalfunctionJun 22, 2017Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 108MG/DL ON THE CONTOUR. HE ALSO TESTED ON THE CONTOUR USB AND THE READINGS WERE 67, 61 AND 24MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR INVESTIGATION. NEW METER AND STRIPS WERE SENT TO HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6660897 ↗

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---.