BRAUN
Received Apr 23, 2025 · Event occurred Mar 20, 2025
Report 1314800-2025-00016 · MDR key 21894280
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
25023FAM
Product problems
- False Negative Result
- False Negative Result
Patient
9 MO · Female
- Fever
- Viral Infection
- Fever
- Viral Infection
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 IN EUROPE REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER 9 MONTH OLD DAUGHTER. THE DEVICE ALLEGEDLY GAVE READINGS BETWEEN 36.2°C AND 36.8°C, AND A FEVER OF 38.6°C WAS LATER CONFIRMED BY A DOCTOR. THE PATIENT WAS DIAGNOSED WITH BRONCHIOLITIS AND PRESCRIBED FEVER REDUCING MEDICATION. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.