inforMED
MalfunctionFLL

BRAUN

Received Aug 28, 2025 · Event occurred Jul 28, 2025

Report 1314800-2025-00023 · MDR key 22919600

Device

Generic name

Forehead Thermometer

Model number

BST200EE

Product problems

  • False Negative Result
  • False Negative Result

Patient

12 MO · Male

  • 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 HER THERMOMETER ALLEGEDLY GAVE A FALSE NEGATIVE READINGS ON HER 1-YEAR-OLD SON. THE DEVICE ALLEGEDLY DISPLAYED A TEMPERATURE OF 36.2°C, WHILE THE CHILD APPEARED UNWELL. DUE TO CONCERNS, THE PARENT CALLED AN AMBULANCE. PARAMEDICS MEASURED THE CHILD'S TEMPERATURE AND OBTAINED A READING OF 39.6°C. THE CHILD WAS LATER DIAGNOSED WITH A SICKNESS BUG AND TEETHING. THERE WERE NO COMPLICATIONS REPORTED FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.