BRAUN
Received Sep 9, 2025
Report 1314800-2025-00024 · MDR key 23012433
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot 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.