inforMED
MalfunctionFLL

BRAUN

Received Jul 2, 2026 · Event occurred May 26, 2026

Report 1314800-2026-00012 · MDR key 25691896

Device

Generic name

Ear Thermometer

Model number

IRT3030

Product problems

  • False Negative Result

Patient

NA · Female

  • Fever

Narrative

Description of Event or Problem

A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY PROVIDED A FALSE NEGATIVE READING ON THEIR CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 37°C, WHILE A FEVER OF 39.5°C WAS LATER CONFIRMED BY A DOCTOR AND TWO OTHER THERMOMETERS USED AT HOME. IT IS UNKNOWN WHETHER THE MEASUREMENTS WERE TAKEN AT THE SAME TIME OR UNDER COMPARABLE CONDITIONS. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

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.