Medline MPH6540Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10888277675674), received between Sep 21, 2026 and Sep 30, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (17 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952416 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "It is not working right. It is taking multiple strips and giving us an error."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947155 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Unexpected Shutdown

  It was reported that "It is spotty to turn on but won't stay on long enough to do the test."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946694 ↗
• MalfunctionSep 30, 2026High Readings; Low Readings

  It was reported that "Today they went to QC a new bottle of strips and the low control is reading high and high reading low."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946544 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that THIS ONE IS OUT OF RANGE >50 I.E. 57 & 58.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946341 ↗
• MalfunctionSep 30, 2026High Readings; Low Readings

  It was reported that "their checks in the morning are consistently a little out of range. The Level 1 is always just slightly higher than range, and the Level 3 is just slightly lower than normal range.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945961 ↗
• MalfunctionSep 30, 2026Failure to Calibrate

  It was reported that "product is not working and will not calibrate."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944883 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  It was reported that the device was not working.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942008 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  It was reported that the device was not working.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941988 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941482 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941446 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937789 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937372 ↗
• MalfunctionSep 29, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937158 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933675 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933208 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932577 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931958 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924870 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924242 ↗
• MalfunctionSep 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918249 ↗
• MalfunctionSep 28, 2026Unable to Obtain Readings

  It was reported that the device is not recognizing the strips.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918129 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906114 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "Customer is getting false readings" and "They are always out of range."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899564 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that they have three Harmony meters that are reading out of range.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897425 ↗