Device adverse event reports (MAUDE)

Dexcom G7 15 Day Continuous Glucose Monitoring System · Continuous Glucose Monitor

Dexcom, Inc. · Wireless Communication Problem

2026-09-30MalfunctionInitial submissionMDR 50941431

Manufacturer contact state

Manufacturer link flag

Manufacturer contact address 1

6340 Sequence Dr.

Manufacturer contact pcity

+1(858)2

Event type

Malfunction

Report number

3004753838-2026-263340

Product problem flag

Date received

20260930

PMA pmn number

K213919

Date of event

20260815

Reprocessed and reused flag

Manufacturer contact zip code

92121

Manufacturer contact plocal

+1(858)200-0200

Noe summarized

Manufacturer contact l name

Chavez

Reporter country code

Date added

20260930

Manufacturer contact f name

Jaime

Previous use code

Reporter state code

Manufacturer contact country

Date changed

20260930

Health professional

Summary report flag

Date report

20260929

Manufacturer contact city

San Diego

MDR report key

50941431

Date manufacturer received

20260908

Report source code

Manufacturer report

Adverse event flag

Single use flag

Manufacturer contact postal code

92121

Type of report

Initial submission

Source type

Consumer

Device

Device sequence number
353649
Serviced by 3rd party flag
N
Date received
20260930
Brand name
Dexcom G7 15 Day Continuous Glucose Monitoring System
Generic name
Continuous Glucose Monitor
Manufacturer d name
Dexcom, Inc.
Manufacturer d address 1
6340 Sequence Dr.
Manufacturer d city
San Diego
Manufacturer d state
CA
Manufacturer d zip code
92121
Manufacturer d country
US
Manufacturer d postal code
92121
Device operator
LAY USER/PATIENT
Catalog number
Unknown
Device availability
No
Device report product code
QBJ
Device evaluated by manufacturer
N
Combination product flag
N
Harmonized identifiers (openFDA)
Device name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Medical specialty description
Clinical Chemistry
Regulation number
862.1355
Device class
2

Product problems

Wireless Communication Problem

Patient

Patient sequence number
1
Date received
20260930
Patient age
74 YR
Patient sex
Male
Patient weight
235 LB
Patient problems
No Clinical Signs, Symptoms or Conditions

How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.