Nova Max Plus (REF 45824)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00385480458245), received between Dec 5, 2019 and Apr 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Imprecision” (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.

• MalfunctionApr 14, 2021Imprecision; No Apparent Adverse Event; Imprecision; No Apparent Adverse Event

  COMPLAINANT CALLED INTO REPORT A HIGH BLOOD GLUCOSE READING. SUBSEQUENT TO TROUBLESHOOTING WITH NOVA MAX GLUCOSE CONTROLS AND TO BACK TO BACK BLOOD GLUCOSE VALUES. THE DIFFERENCE WAS DETERMINED TO BE CLINICALLY SIGNIFIGANT.

  Patient problems: Hyperglycemia

  MAUDE report 11665973 ↗
• MalfunctionDec 5, 2019No Display/Image; No Display/Image

  THE COMPLAINANT REPORTED E1 (SYSTEM HARDWARE ERROR) - NOT REPORTABLE FAILURE, AS SOON AS SHE INSERTED THE TEST STRIP INTO THE METER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9417786 ↗