BREEZE® 2 1465ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20301931465505), received between Jun 9, 2017 and Jul 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2017Incorrect Measurement; Incorrect Measurement

  ADVOCATE STATED HIS WIFE'S BLOOD GLUCOSE READING ON THE BREEZE2 WAS 60-100 MG/DL DIFFERENT THAN THE READING ON THE PHARMACY METER. CUSTOMER HAD SYMPTOMS FOR HIGH BLOOD GLUCOSE. SPECIFIC INFORMATION WAS NOT PROVIDED. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCE BETWEEN THEM COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE ADVOCATE WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6749898 ↗
• MalfunctionJun 9, 2017Low Readings

  THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 40MG/DL ON THE BREEZE2, RETESTED ON A DIFFERENT METER AND THE READING WAS OVER 200MG/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. NEW METER AND TEST STRIPS WERE SENT TO HIM.

  Patient problems: Hyperglycemia

  MAUDE report 6629389 ↗