BRAUN
Received Feb 7, 2025
Report 1314800-2025-00005 · MDR key 21333608
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
28023FAM
Product problems
- False Negative Result
- False Negative Result
Patient
10 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 REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER 10-MONTH-OLD DAUGHTER. THE DEVICE ALLEGEDLY GAVE READINGS OF 36.3°C, AND A FEVER OF 39°C WAS LATER MEASURED BY A PARAMEDIC. THE CONSUMER PROVIDED PARACETAMOL TO HER DAUGHTER WHICH COULD HAVE IMPACTED THE DEVICE'S TEMPERATURE READING. THE CHILD WAS DIAGNOSED WITH A VIRAL INFECTION AND IS CURRENTLY RECOVERING, NOW IN GOOD HEALTH. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.