Medline MPH4540Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888277409163), received between Jun 30, 2023 and Sep 30, 2026 — classified as 3 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948652 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that "Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944509 ↗
• MalfunctionSep 30, 2026Low Readings

  It was reported that 1 OUT OF THE 6 GLUCOSE METERS ORDERED (ITEM#: MPH4540) WERE DEFECTIVE AND INCORRECTLY READING GLUCOSE LEVELS. SHE ADVISED WHEN LEVEL 2 TEST STRIPS ARE ENTERED, THE READING SHOULD BE BETWEEN 74-99 AND THIS ITEM KEPT HAVING A READING OF 71.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941911 ↗
• MalfunctionSep 29, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938294 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936611 ↗
• MalfunctionSep 29, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936279 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "Meter not reading accurately."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932285 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923228 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916995 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that "Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916356 ↗
• MalfunctionSep 28, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915164 ↗
• MalfunctionSep 28, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913690 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that "Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902413 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  It was reported that "replaced and put new batteries in. Will not turn on."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900232 ↗
• MalfunctionSep 25, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the batteries don¿t last, the display gradually goes dark, and the meter does not have consistent readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899449 ↗
• MalfunctionSep 24, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888642 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that Batteries don't last. The display gradually goes dark. Does not have a consistent reading, which puts the whole machine in question.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882502 ↗
• MalfunctionSep 23, 2026High Readings

  Patient problems: Insufficient Information

  MAUDE report 50872642 ↗
• MalfunctionSep 23, 2026Computer Software Problem; Unable to Obtain Readings

  It was reported that "ERR4 before even counting down and it definitely has enough blood and testing solution." "It throws an error at four before it even starts counting down."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870182 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "CUST IS RECEIVING INACCURATE READINGS ON THEIR METER FOR THE CONTROL TESTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869872 ↗
• MalfunctionSep 23, 2026Computer Software Problem; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "The batteries don¿t last long and the display gradually goes dark. The customer also explained that the meter does not have consistent readings."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869594 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that ¿HAVE TO RUN CONTROLS 3-6 TIMES TO GET IT IN RANGE - HAVE CHANGED CONTROLS AND STRIPS MULTIPLE TIMES AND IT IS STILL DOING THAT¿; ¿THERE ARE 3 TOTAL DOING THIS.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868072 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861110 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860502 ↗
• MalfunctionSep 22, 2026Unable to Obtain Readings; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860205 ↗