CONTOUR® 7099CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10301937099509), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2017Incorrect, Inadequate or Imprecise Result or Readings

  EMT STATED THEY WERE CALLED BECAUSE A PERSON WAS FOUND LYING ON THE FLOOR. THEY TESTED THE INDIVIDUAL'S BLOOD WITH THE CONTOUR AND THE READING WAS 64MG/DL. EMT GAVE THE PATIENT 24G OF GLUCOSE GEL. HE WAS NOT SURE IF THE GEL WAS GIVEN BEFORE OR AFTER THE BLOOD TEST. THE PATIENT SHOWED LITTLE RESPONSE TO THE GEL, SO THE EMT CALLED THE FIRE DEPARTMENT. THEY RETESTED THE PATIENT WITH THEIR CONTOUR AND THE READING WAS 28MG/DL. THE PATIENT WAS GIVEN A DEXTROSE50 INJECTION AND THEN WAS FEELING BETTER. SHE WAS GIVEN SOMETHING TO EAT. THE DIFFERENCE BETWEEN READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER RETURNED THE TEST STRIPS FOR INVESTIGATION. NEW METER AND STRIPS WERE SENT TO HIM.

  Patient problems: Hypoglycemia

  MAUDE report 6608600 ↗

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---.