EasyMax NG Self-Monitoring Blood Glucose System EMMU (UDI 00885017000065)Recalls & reported problems
Eps Bio Technology Corp. · Semi kit: one blood glucose meter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885017000065), received between Nov 28, 2024 and May 8, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Calibration Problem2
- Failure to Power Up1
- Human-Device Interface Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Human-Device Interface Problem; Human-Device Interface Problem
THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00014 (FILE NAME: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21982587 ↗MalfunctionFeb 6, 2025Failure to Power Up; Failure to Power Up
THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00011 (FILE NAME: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319634 ↗MalfunctionFeb 6, 2025Calibration Problem; Calibration Problem
THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00010 (FILE NAME: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319419 ↗MalfunctionNov 28, 2024Calibration Problem; Calibration Problem
THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2024-00007 (FILE NAME: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803772 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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