inforMED
InjuryFLL

BRAUN

Received Mar 14, 2025

Report 1314800-2025-00009 · MDR key 21606142

Device

Generic name

Ear Thermometer

Model number

IRT3030EE

Lot number

UNKNOWN

Product problems

  • False Negative Result
  • False Negative Result

Patient

NA · Male

  • Fever
  • Sepsis
  • Fever
  • Sepsis

Narrative

Additional Manufacturer Narrative

KAZ USA, INC. HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS INCIDENT, AND ALSO THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

Description of Event or Problem

THE CONSUMER ALLEGED THAT THE THERMOMETER MEASURED FALSE NEGATIVE READINGS, RESULTING IN A DELAY OF ANTIPYRETIC INTAKE (PARACETAMOL) AND A DELAY OF TREATMENT DUE TO LATE VISIT TO A DOCTOR. THE CONSUMER DID NOT SPECIFY WHAT THE ALLEGED FAULTY TEMPERATURE READINGS WERE, BUT FIVE DAYS AFTER EXPERIENCING FEVER SYMPTOMS, HE VISITED THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH NEUTROPENIC SEPSIS BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.