Medline MPH3540Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884389831199), received between Nov 21, 2019 and Sep 30, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K113098, K120448); they may or may not involve this specific model.

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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  It was reported that "SHE JUST OPENED ONE OF THE METERS TO USE AND IT IS DEFECTIVE. WHEN THEY PUT THE STRIP IN THE MACHINE TO TURN ON IT GOES TO A SAD FACE THEN TURNS OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950144 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that UNIT HAS FAILED API TESING. THEY USE AMERICAN PROFICIENCY INSTITUTE LABS TO TEST THE MONITORS QUARTERLY, AND THIS UNIT FAILED THEIR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947854 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935439 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932976 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932916 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932886 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932850 ↗
• MalfunctionSep 28, 2026Computer Software Problem; Visual Prompts will not Clear

  It was reported that 9C WILL NOT CLEAR OFF OF MONITOR TO ALLOW FOR REGULAR READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916994 ↗
• MalfunctionSep 24, 2026Low Readings

  It was reported that the Meter is not passing low solution testing. the High Solution QC test is passing just fine; only the low QC test is failing consistently.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883462 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  The report states, "The EvenCare glucometer (MPH3540) started showing a low battery indicator a few days ago. They have changed the battery multiple times and continue to receive the same low batter indicator on the screen before the unit shuts off. They are unable to use the meter. Could not resolve."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882090 ↗
• MalfunctionSep 23, 2026Low Readings

  It was reported that "THE METERS KEEP RUNNING LOW IN RANGE WHEN RUNNING CONTROLS - NOT IN THE RANGE OF NUMBERS IT SHOWS IT SHOULD BE IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872374 ↗
• MalfunctionSep 23, 2026Unable to Obtain Readings

  It was reported that GETTING ERRO 2 ON METER. OPENED UP NEW BOTTLE OF STRIPS AND METER STILL GIVE ERROR 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870197 ↗
• MalfunctionSep 23, 2026Low Readings

  It was reported that 1EA of their (b)(6) glucometers is reading low control solution out of range of what is printed on the strip bottle. I asked customer to try again while on the phone and it read 33 while the test strip bottle states 39-69.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868675 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859910 ↗
• MalfunctionSep 22, 2026Low Readings

  It was reported that "We are using the EvenCare G3 Blood Glucose Test Strips, running the EvenCare G3 Glucose Control Solutions and getting incorrect numbers that are not in range."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859618 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  It was reported that "GAVE ERROR 2 AND SHUT OFF. NOW IT WILL NOT TURN BACK ON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859091 ↗
• MalfunctionSep 21, 2026Computer Software Problem; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849351 ↗
• MalfunctionSep 21, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847588 ↗
• MalfunctionSep 21, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842394 ↗
• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841589 ↗
• MalfunctionSep 21, 2026Computer Software Problem; Display or Visual Feedback Problem

  It was reported that "EVENCARE G3 TURN IT ON - FROWN FACE - REPLACED BATTERY AND IT STILL IS NOT WORKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838124 ↗
• MalfunctionSep 17, 2026Computer Software Problem; Low Readings

  It was reported that "their EvenCare G3 glucometer was repeatedly giving an \"error 2\" message indicating that the account needed to use new test strips despite the account using a new bottle of un-expired test strips." Additionally, "their bottle of \"low\" control solution has repeatedly been reading lower than the designated range."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801122 ↗
• MalfunctionMay 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PER REPORT, "GLUCOSE MONITOR READINGS OFF. IT WAS READING AT 52 AND WAS SUPPOSED TO COME OUT AT 38 MG FOR THE CONTROL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263295 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PER CUSTOMER, "EVEN CARE G3 GLUCOSE METERS NOT READING IN RANGE WITH THE TEST STRIPS AND CONTROLS. I WAS TOLD IT MUST BE A METER ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097441 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PER CUSTOMER, "EVEN CARE G3 GLUCOSE METERS NOT READING IN RANGE WITH THE TEST STRIPS AND CONTROLS. I WAS TOLD IT MUST BE A METER ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113098, K120448. One submission often covers many models, so check the product and lot details in each record.

• Z-0513-2020 · Sep 18, 2019 · Terminated
  EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.