BRAUN
Received Oct 2, 2025 · Event occurred Sep 2, 2025
Report 1314800-2025-00025 · MDR key 23201958
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot 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.