inforMED
MalfunctionFLL

BRAUN

Received Dec 12, 2024 · Event occurred Nov 11, 2024

Report 1314800-2024-00024 · MDR key 20916202

Device

Generic name

Forehead Thermometer

Model number

BNT300WE

Lot number

UNKNOWN

Product problems

  • False Negative Result
  • False Negative Result

Patient

7 MO · Unknown

  • Fever
  • Convulsion/Seizure
  • Fever
  • Convulsion/Seizure

Narrative

Description of Event or Problem

A EUROPEAN CONSUMER REPORTED THAT THEIR BRAUN NO TOUCH THERMOMETER (BNT300) HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR SON. THE DEVICE ALLEGEDLY GAVE A READING OF 38°C, AND A FEVER OF 41°C WAS CONFIRMED BY A DOCTOR. THE CUSTOMER CLAIMED THAT BECAUSE OF HIGH FEVER IT CAUSED SEIZURE AND LEAD TO A MORE AGGRESSIVE TREATMENT. THEY ALSO ATTESTED THAT THE DIAGNOSIS OF AN ILLNESS WAS DELAYED DUE TO THIS POTENTIAL INACCURACY. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

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.