inforMED
MalfunctionFLL

BRAUN

Received Feb 4, 2025 · Event occurred Jan 6, 2025

Report 1314800-2025-00003 · MDR key 21306613

Device

Generic name

Ear Thermometer

Model number

IRT3030WE

Product problems

  • False Negative Result
  • False Negative Result

Patient

13 MO · Prefer Not To Disclose

  • Fever
  • Fever

Narrative

Description of Event or Problem

A PHARMACY REPORTED THAT A CONSUMER RETURNED A THERMOMETER WHICH HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 36.5°C, AND A FEVER OF 39°C WAS LATER MEASURED BY A DOCTOR. IT IS UNKNOWN WHETHER THE CONSUMER TOOK A MEASUREMENT ON THE SAME DAY AS THEY WERE BROUGHT TO A DOCTOR, WHERE A FEVER WAS CONFIRMED. 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.