BRAUN
Received Mar 14, 2025
Report 1314800-2025-00009 · MDR key 21606142
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030EELot number
UNKNOWN
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Male
- Fever
- Sepsis
- Fever
- Sepsis
Narrative
Additional Manufacturer Narrative
KAZ USA, INC. HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS INCIDENT, AND ALSO THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem
THE CONSUMER ALLEGED THAT THE THERMOMETER MEASURED FALSE NEGATIVE READINGS, RESULTING IN A DELAY OF ANTIPYRETIC INTAKE (PARACETAMOL) AND A DELAY OF TREATMENT DUE TO LATE VISIT TO A DOCTOR. THE CONSUMER DID NOT SPECIFY WHAT THE ALLEGED FAULTY TEMPERATURE READINGS WERE, BUT FIVE DAYS AFTER EXPERIENCING FEVER SYMPTOMS, HE VISITED THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH NEUTROPENIC SEPSIS BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.