Medline MPH1545Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884389102407), received between May 22, 2026 and Sep 30, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951221 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "GLUCOSE METER GIVING DIFFERENT READINGS THROUGH OUT THE DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947571 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings

  It was reported that ¿THEY TRIED USING THE GLUCOSE MACHINE BUT IT DOES NOT READ. MB STATES THEY TRIED MULTIPLE TIMES BUT THE READINGS NEVER APPEAR.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946361 ↗
• MalfunctionSep 25, 2026Low Readings

  It was reported that "HIS GLUSCOSE MONITOR IS NOT READING CORRECTLY FOR THE LOW RANGE OF THE TEST SOLUTION" and "THE DEVICE IS NOT READING WITHIN THE ALOTTED RANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900185 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889987 ↗
• MalfunctionSep 24, 2026Unable to Obtain Readings

  It was reported that "When the customer inserts a test strip into the meter the strip continues to flash at the bottom of the screen. customer has tried different strips but could not reslove issue."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886618 ↗
• MalfunctionSep 24, 2026Low Readings

  It was reported that "HER METER IS NOT READING CORRECTLY GIVING LOW READINGS ALMOST EVERYDAY BELOW 20 OR GIVING OUT ERR4 ERROR. AND 1 READING WAS 48 BUT THE REMAINING WERE LOW. VOICE STATES UNDER 20."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883009 ↗
• MalfunctionSep 23, 2026Device Provides Uninformative Message

  It was reported that the device is producing an error message.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869695 ↗
• MalfunctionSep 23, 2026Unable to Obtain Readings

  It was reported that "RECEIVED DEFECTIVE GLUCOMETER, SHE PUTS IN GLUCOSE TEST STRIP AND SCREEN DOES NOT READ ANY GLUCOSE LEVELS. SHE HAS TRIED WITH SEVERAL STRIPS AND READ THE INSTRUCTIONS BUT NOTHING WORKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867201 ↗
• MalfunctionSep 22, 2026Computer Software Problem; Unable to Obtain Readings

  It was reported that "When the test strips are inserted the screen does not light up to show the blood sugar count. Member has confirmed the battery is inserted correctly and is in good condition."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857344 ↗
• MalfunctionSep 21, 2026Computer Software Problem; Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847338 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840549 ↗
• MalfunctionSep 21, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840230 ↗
• MalfunctionSep 21, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839698 ↗
• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839276 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  It was reported that "ITEM #MPH1545,STARTER KIT, GLUCOSE, EVENCARE G2 1EA DOES NOT WORK, ITEM DOES NOT RECONIZE THE TEST STRIP THAT CAME INCLUDED IN THE KIT, MB STATED HE CALIBRATED THE MACHINE AND IT DOES NOT WORK, HE STATED HE TRY USING MULTIPLE TEST STRIPS AND IS NOT READING THE TEST STRIPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838919 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported that "LANCING DEVICE IS NOT PROPERLY WOKRING TO ALLOW THE LANCET TO PUCTURE THE SKIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801152 ↗
• MalfunctionMay 22, 2026Image Display Error/Artifact

  PER THE REPORT, "CUSTOMER CALLED IN STATING HER GLUCOSE MONITOR IS NOT WORKING PROPERLY. HER GLUCOSE READINGS ARE OFF AND GIVING AN ERROR MESSAGE. ALSO MENTIONED THE LOW QUALITY OF THE MACHINE AND UNHAPPY WITH THE PRODUCT. REQUESTED REPLACEMENT MONITOR ASAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262719 ↗