inforMED
MalfunctionPQM

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Received Feb 9, 2018 · Event occurred Jan 13, 2018

Report 3004753838-2018-014821 · MDR key 7261852

Device

Generic name

Continuous Glucose Monitor

Manufacturer

Dexcom, Inc.

Model number

N/A

Catalog number

SW10611

Product problems

  • Wireless Communication Problem
  • Wireless Communication Problem

Patient

60 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

PT REPORTED SIGNAL LOSS ON (B)(6).

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED