MalfunctionFLL
BRAUN
Received Jan 17, 2025 · Event occurred Dec 17, 2024
Report 1314800-2025-00001 · MDR key 21182017
Device
Product problems
- False Negative Result
- Insufficient Device Problem Information
- False Negative Result
- Insufficient Device Problem Information
Patient
12 MO · Prefer Not To Disclose
- Fever
- Fever
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR THERMOMETER HAD GIVEN FALSE NEGATIVE READINGS ON THEIR TWO BABIES. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE APPROXIMATELY 2.6°C-3.1°C LOWER THAN WHAT WAS LATER MEASURED BY A DOCTOR. THERE WERE NO REPORTED COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE DEVICE BE RETURNED TO OUR COMPANY FOR TESTING.
Additional Manufacturer Narrative
KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.