inforMED
MalfunctionFLL

BRAUN

Received Nov 5, 2025 · Event occurred Sep 27, 2025

Report 1314800-2025-00029 · MDR key 23479393

Device

Generic name

Ear Thermometer

Model number

IRT3030WE

Lot number

13623FAM

Product problems

  • False Negative Result
  • False Negative Result

Patient

NA · 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 THEIR THERMOMETER ALLEGEDLY PROVIDED FALSE NEGATIVE READINGS ON THEIR CHILD (AGE NOT SPECIFIED). THE DEVICE ALLEGEDLY DISPLAYED 36-37°C, WHILE A SUBSEQUENT RECTAL MEASUREMENT AND AN ALTERNATE DIGITAL EAR THERMOMETER (BRAND UNSPECIFIED) INDICATED A FEVER OF 39°C. IT IS UNCLEAR WHETHER THE 39°C READING WAS CONFIRMED BY A PHYSICIAN'S THERMOMETER. THE CONSUMER STATED THAT TREATMENT WAS DELAYED AND THAT THEY CONSULTED A PEDIATRICIAN. NO COMPLICATIONS WERE REPORTED, AND THE CHILD'S OUTCOME IS UNKNOWN. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.