MalfunctionFLL
BRAUN
Received Dec 31, 2025 · Event occurred Nov 29, 2025
Report 1314800-2025-00031 · MDR key 23936285
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
19824FAM
Product problems
- False Negative Result
- False Negative Result
Patient
30 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 THE THERMOMETER ALLEGEDLY PROVIDED FALSE NEGATIVE READINGS ON THEIR 2.5 YEAR OLD CHILD. THE DEVICE ALLEGEDLY DISPLAYED REPEATED MEASUREMENTS OF 36.4°C, AND A FEVER OF 39.5°C WAS LATER MEASURED BY A PHYSICIAN USING AN UNSPECIFIED DEVICE. THE CHILD'S DIAGNOSIS WAS NOT DISCLOSED. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.