inforMED
MalfunctionFLL

BRAUN

Received Oct 2, 2025 · Event occurred Sep 2, 2025

Report 1314800-2025-00025 · MDR key 23201958

Device

Generic name

Ear Thermometer

Model number

IRT3030WE

Lot number

24824FAM

Product problems

  • False Negative Result
  • False Negative Result

Patient

4 MO · Unknown

  • Fever
  • Fever

Narrative

Additional Manufacturer Narrative

KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

Description of Event or Problem

A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR FIVE-MONTH-OLD CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 36.7°C, AND A FEVER OF 38.8°C WAS LATER MEASURED BY A PARAMEDIC WITH A PROFESSIONAL IN-EAR THERMOMETER. THE CONSUMER STATED THAT THIS DISCREPANCY LED TO A DELAY IN SEEKING MEDICAL ATTENTION. IT IS NOTED THAT THE PROBE WAS NOT CLEANED WITH A CLEANING AGENT PRIOR TO THE MEASUREMENT. THE CHILD WAS DIAGNOSED WITH FEVER, NO MEDICATION WAS PRESCRIBED, AND THE CHILD IS CURRENTLY HEALTHY. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.