CONTOUR® 7098CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10301937098502), received between Jun 22, 2018 and Oct 31, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “High Readings” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT AT 6:42 A.M., HE OBTAINED A BLOOD GLUCOSE READING OF 90 MG/DL ON HIS CONTOUR METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS SUCH AS CONFUSION AND SWEATING. HE ATE 2 EGGS FOR BREAKFAST AND WAS STILL FEELING UNWELL. THE CUSTOMER'S WIFE CALLED PARAMEDICS, WHO RAN BLOOD TEST ON THEIR METER AND OBTAINED A READING OF 59 MG/DL AT 7:42 A.M. PARAMEDICS GAVE STRAWBERRY JUICE AND A SLICE OF BREAD TO THE CUSTOMER TO INCREASE HIS BLOOD GLUCOSE LEVELS, AFTER WHICH HE FELT BETTER. AT 9:10 A.M., PARAMEDICS RAN ANOTHER TEST ON THEIR METER AND OBTAINED A READING OF 79 MG/DL. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Confusion/ Disorientation; Sweating

  MAUDE report 9261736 ↗
• InjuryJul 30, 2018High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 450MG/DL ON THE CONTOUR. SHE REACTED BY TAKING 500MG/DL OF METFORMIN. UNLESS HER BLOOD GLUCOSE IS HIGH, SHE DOES NOT TAKE THE MEDICATION. AS SOON AS SHE TOOK THE MEDICATION SHE STARTED TO FEEL NAUSEOUS AND HER LEFT EYE WAS SHAKING, SO SHE TOOK A HOT BATH. UPON GETTING OUT OF THE BATHTUB SHE PASSED OUT FOR A COUPLE OF MINUTES. HER DAUGHTER HELP HER GET UP, AND IMMEDIATELY GAVE HER ORANGE JUICE AND COFFEE. SHE ALSO ATE A BOWL OF WHITE RICE AND STARTED FEELING BETTER. SHE WENT TO THE HOSPITAL. OTHER THAN THE DOCTOR TELLING HER THE METER WAS NOT WORKING AND SUGGESTING SHE GET ANOTHER ONE, FURTHER INFORMATION WAS NOT PROVIDED. HER DOCTOR CHANGED HER MEDICATION AND REMOVED THE METFORMIN FROM HER PRESCRIPTION SINCE SHE COULD HAVE AN ALLERGIC REACTION TO IT. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HER.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7732053 ↗
• InjuryJun 22, 2018High Readings; High Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 340MG/DL ON THE CONTOUR, USING EXPIRED STRIPS. SHE TOOK HER REGULAR INSULIN BASED ON THE READING, AND STARTED TO FEEL DIZZY AND LIGHTHEADED. AN AMBULANCE WAS CALLED AND, BASED ON HER SYMPTOMS, SHE WAS GIVEN GLUCOSE BY MOUTH. INFORMATION ON WHETHER OR NOT THE CUSTOMER WAS ABLE TO SELF TREAT WAS NOT PROVIDED. NO BLOOD TEST WAS RUN BY THE PARAMEDICS. HER MEDICAL CONDITION BECAME STABLE. THE CUSTOMER WAS ADVISED TO RETURN THE EXPIRED STRIPS. NEW METER AND STRIPS WERE SENT TO HER.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 7629624 ↗

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---.