OtherQBJ

FREESTYLE LIBRE 3 PLUS SENSOR

Received Sep 22, 2025 · Event occurred Sep 16, 2025

Report MW5176298 · MDR key 23109948

Device

Generic name

Integrated Continuous Glucose Monitoring System, Factory Calibrated

Manufacturer

Flextronics America, Llc

Product problems

Defective Device

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MALFUNCTION WITH ONE OF THE DEVICES. REPORTED BY HEALTHCARE PROVIDER OFFICE. HEALTHCARE PROVIDER OFFICE DID NOT CONSENT TO FOLLOW UP. NO FURTHER INFORMATION/CLARIFICATION AVAILABLE. (B)(4).