inforMED
MalfunctionFLL

BRAUN

Received Aug 24, 2025

Report 1314800-2025-00022 · MDR key 22881487

Device

Generic name

Forehead Thermometer

Model number

BNT400WE

Lot number

28223TAV

Product problems

  • False Negative Result
  • False Negative Result

Patient

10 YR · Female

  • Fever
  • Viral Infection
  • Fever
  • Viral Infection

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 HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER 10-YEAR-OLD DAUGHTER. THE DEVICE ALLEGEDLY DID NOT DETECT A FEVER, WHILE A TEMPERATURE OVER 40°C WAS LATER MEASURED BY AMBULANCE PERSONNEL AND CONFIRMED AT THE HOSPITAL. THE EXACT READINGS DISPLAYED BY THE THERMOMETER WERE NOT PROVIDED. THE CHILD WAS ADMITTED TO THE HOSPITAL AND TREATED WITH ANTIBIOTICS AND IV FLUIDS, AND WAS LATER DIAGNOSED WITH FLU B. SHE IS CURRENTLY UNDER FOLLOW-UP CARE WITH A PEDIATRICIAN FOR KIDNEY CONCERNS AND A CARDIOLOGIST. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.