inforMED
MalfunctionQDK

DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

Received May 30, 2025 · Event occurred Apr 30, 2025

Report 3004753838-2025-134153 · MDR key 22113990

Device

Generic name

Continuous Glucose Monitor

Manufacturer

Dexcom, Inc.

Catalog number

STT-OE-002

Lot number

17999208

Product problems

  • Wireless Communication Problem
  • Wireless Communication Problem

Patient

37 YR · Female

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, WHICH IS MISUSE OF THE DEVICE. 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.

Additional Manufacturer Narrative

(B)(4).