Medline MPH1545BTRecalls & reported problems
Medline Industries, Inc. · STARTER KIT, GLUCOSE, EVENCARE G2 BT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00197344007595), received between Sep 21, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Computer Software Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948690 ↗MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the glucose monitor is not working properly and believes it is defective. The device is not reading accurately or giving accurate readings.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842615 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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