inforMED
MalfunctionQII

DEXCOM G6 PROFESSIONAL SYSTEM

Received Dec 3, 2024 · Event occurred Nov 10, 2024

Report 3004753838-2024-316501 · MDR key 20838005

Device

Generic name

Continuous Glucose Monitor

Manufacturer

Dexcom, Inc.

Catalog number

STP-PR-001

Lot number

NI

Product problems

  • Premature End-of-Life Indicator
  • Premature End-of-Life Indicator

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.