EasyMax V Self-Monitoring Blood Glucose System EMVRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885017000058), received between Nov 4, 2018 and Jul 29, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Calibration Problem; Calibration Problem

  ERR MESSAGE OF THE SELF-MONITORING BLOOD GLUCOSE METER (MODEL EMV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640754 ↗
• MalfunctionJun 5, 2025Fitting Problem; Fitting Problem

  THE CUSTOMER COMPLAINED THAT THE CONTROL SOLUTION WAS OUT OF RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147878 ↗
• MalfunctionMay 8, 2025No Display/Image; No Display/Image

  THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00016 (FILE NAME: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982853 ↗
• MalfunctionMay 6, 2025Failure to Power Up; Failure to Power Up

  CUSTOMER COMPLAINTED THAT THE METER HAS A NO POWER PROBLEM. NO POWER OF THE SELF-MONITORING BLOOD GLUCOSE METER. (MODEL EMV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965441 ↗
• MalfunctionFeb 7, 2025Fitting Problem; Fitting Problem

  CUSTOMER COMPLAINTED THAT THE CONTROL SOLUTION OUT OF THE RANGE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330064 ↗
• MalfunctionNov 28, 2024No Display/Image; No Display/Image

  BAD DISPLAY OF THE SELF-MONITORING BLOOD GLUCOSE METER (MODEL EMV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803737 ↗
• MalfunctionNov 20, 2024Failure to Power Up; Failure to Power Up

  THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00006 (FILE NAME: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741611 ↗
• MalfunctionOct 21, 2024Calibration Problem; Calibration Problem

  THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00002 (FILE NAME: (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490930 ↗
• MalfunctionOct 4, 2024Calibration Problem; Calibration Problem

  ERROR MESSAGE OF THE SELF-MONITORING BLOOD GLUCOSE METER (MODEL EMV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20366404 ↗
• MalfunctionNov 4, 2018No Apparent Adverse Event; No Apparent Adverse Event

  WE RECEIVED A VOLUNTARY EVENT REPORT FROM FDA WITH REPORT NUMBER: MW5079747. WE CONTACTED THE PATIENT AND SHE SAID SHE GOT HIGH READINGS OF 443/507/499 MG/DL FROM THE EASYMAX V GLUCOSE METER. BECAUSE THE PATIENT IS ON A SLIDING SCALE AND DIDN'T WANT TO GIVE HERSELF THAT MUCH INSULIN, SHE CALLED THE EMS AND RECEIVED ONLY 204 MG/DL. SHE BROUGHT THIS DEVICE ABOUT A YEAR AGO AND NEVER DROPPED THE DEVICE. SHE DID NOT LEAVE THE TEST STRIP VIAL UNCLOSED AND STORES IN THE KITCHEN CABINET. SHE DID NOT HAVE AND USE THE CONTROL SOLUTION TO CHECK THE DEVICE AND TEST STRIP. REPLACE PRODUCT TO HER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8036521 ↗