NOVA MAX GLURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10385480434376), received between Mar 3, 2017 and Apr 3, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CONSUMER STATED HE IS CONCERNED ABOUT HIGH BLOOD GLUCOSE (BG) READINGS. THE CONSUMER STATED HE WAS FEELING A "BIT LOW", ACCORDING TO THE CONSUMER, HE FELT "WEAK AND TIRED" WHEN HE TESTED AT 11:48PM BEFORE GOING TO BED, THEREFORE HE GAVE HIMSELF AT LEAST "2-3 MORE UNITS OF INSULIN" AFTER HE TESTED. THE CONSUMER ADMINISTERED A TOTAL OF 7.4MM UNITS OF INSULIN. THE CONSUMER DOES NOT RECALL THE DOSAGE OF INSULIN SUGGESTED BY HIS PUMP FOR THIS READING. THE CONSUMER DID NOT SAY WHAT HIS READING SHOULD HAVE BEEN INSTEAD OF THE 309 BG RESULT. ACCORDING TO THE CONSUMER, HE TREATS HIMSELF BASED ON HOW HE FEELS, THE CONSUMER KNOWS WHEN TO ADMINISTER MORE OR LESS INSULIN. CONSUMER'S HCP IS AWARE AND "IS OKAY WITH CONSUMER ADJUSTING HIS INSULIN INTAKE SINCE HE KNOWS HIS SYMPTOMS WELL AND ACTS ACCORDINGLY" THE CONSUMER WENT TO BED A LITTLE AFTER 11:48PM AND WOKE UP AT 2:46AM FEELING CONFUSED, WEAK AND HAD BLURRED VISION. THE CONSUMER IMMEDIATELY TESTED HIS BG AND GOT THE RESULT OF 178, THE CONSUMER DID NOT TAKE INSULIN, HE INSTEAD ATE CHEESE WITH CRACKERS AND MILK. THE CONSUMER "RELAXED FOR A FEW MINUTES AND FELT HIMSELF RECOVERING". THE CONSUMER WENT TO BACK TO SLEEP ONCE HE STARTED FEELING

  Patient problems: Hypoglycemia; Patient Problem/Medical Problem

  MAUDE report 9922025 ↗
• MalfunctionAug 22, 2018Improper or Incorrect Procedure or Method

  MOTHER OF CONSUMER CALLED IN TO REPORT HIGH BLOOD GLUCOSE LEVELS. THE CONSUMER IS ON SLIDING SCALE FOR INSULIN DOSE. THE CALLER DID NOT FOLLOW THE SLIDING SCALE, SHE TREATED THE CONSUMER BASED OFF WHAT SHE "THOUGHT WAS RIGHT".

  Patient problems: Hyperglycemia

  MAUDE report 7805704 ↗
• MalfunctionMay 8, 2018Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED IN REPORTING HIGH READINGS AND SPECIFICALLY AN INCIDENT ON (B)(6) 2018 WHERE SHE BECAME LIGHT HEADED AND NAUSEOUS WHILE AT A RACETRACK WITH HER BOYFRIEND.

  Patient problems: Nausea

  MAUDE report 7494680 ↗
• MalfunctionMar 3, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CONSUMER CALLED IN REPORTING HIGH BLOOD GLUCOSE RESULTS USING HER NOVA MAX PLUS METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6376421 ↗