BRAUN

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

A HOSPITAL REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON A PATIENT WHO WAS FEBRILE DUE TO HIGH LEUKOCYTES CAUSED BY AN INFECTION. THE DEVICE ALLEGEDLY GAVE A READING OF 34°C, AND A FEVER OF 39°C WAS CONFIRMED BY A MEDICAL PROFESSIONAL USING A MERCURY THERMOMETER. NO INFORMATION WAS PROVIDED ON THE DIAGNOSIS OR CURRENT STATUS OF THE PATIENT. THE ONLY KNOWN INFORMATION PROVIDED WAS THAT A FEVER WAS CONFIRMED BY A MEDICAL PROFESSIONAL, AND OUR DEVICE WAS GIVING FALSE NEGATIVE READINGS. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.