inforMED
MalfunctionFLL

BRAUN

Received Sep 9, 2025

Report 1314800-2025-00024 · MDR key 23012433

Device

Generic name

Ear Thermometer

Model number

IRT3030WE

Lot number

31124FAM

Product problems

  • False Negative Result
  • False Negative Result

Patient

9 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 PHARMACY REPORTED THAT A CONSUMER RETURNED A THERMOMETER WHICH HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON HER 9-MONTH-OLD CHILD WHO HAD ALREADY BEEN ILL WITH A VIRAL INFECTION FOR FIVE DAYS. THE DEVICE ALLEGEDLY GAVE A READING OF 37.5°C IN THE EAR, AND A FEVER OF 40.0°C WAS LATER MEASURED BY A DOCTOR. THE PATIENT WAS DIAGNOSED WITH A VIRAL INFECTION AND IS CURRENTLY RECOVERING, WITH ONLY A SORE THROAT REMAINING. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.