MalfunctionFLL
BRAUN
Received Feb 4, 2025 · Event occurred Jan 6, 2025
Report 1314800-2025-00003 · MDR key 21306613
Device
Product problems
- False Negative Result
- False Negative Result
Patient
13 MO · Prefer Not To Disclose
- Fever
- Fever
Narrative
Description of Event or Problem
A PHARMACY REPORTED THAT A CONSUMER RETURNED A THERMOMETER WHICH HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 36.5°C, AND A FEVER OF 39°C WAS LATER MEASURED BY A DOCTOR. IT IS UNKNOWN WHETHER THE CONSUMER TOOK A MEASUREMENT ON THE SAME DAY AS THEY WERE BROUGHT TO A DOCTOR, WHERE A FEVER WAS CONFIRMED. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
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.