Device adverse event reports (MAUDE)

Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor

Dexcom, Inc. · Wireless Communication Problem

MalfunctionInitial submissionMDR 50941434
Manufacturer contact state
CA
Manufacturer link flag
Y
Manufacturer contact address 1
6340 Sequence Dr.
Manufacturer contact pcity
+1(858)2
Event type
Malfunction
Report number
3004753838-2026-263338
Product problem flag
Y
Date received
20260930
PMA pmn number
K213919
Date of event
20260921
Reprocessed and reused flag
N
Manufacturer contact zip code
92121
Manufacturer contact plocal
+1(858)200-0200
Noe summarized
1
Manufacturer contact l name
Chavez
Reporter country code
US
Date added
20260930
Manufacturer contact f name
Jaime
Previous use code
I
Reporter state code
CA
Manufacturer contact country
US
Date changed
20260930
Health professional
N
Summary report flag
N
Date report
20260929
Manufacturer contact city
San Diego
MDR report key
50941434
Date manufacturer received
20260921
Report source code
Manufacturer report
Adverse event flag
N
Single use flag
Y
Manufacturer contact postal code
92121
Type of report
Initial submission
Source type
Consumer
Device
  1. Device sequence number
    353650
    Serviced by 3rd party flag
    N
    Date received
    20260930
    Brand name
    Dexcom G7 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
  1. Patient sequence number
    1
    Date received
    20260930
    Patient age
    20 YR
    Patient sex
    Male
    Patient weight
    220 LB
    Patient problems
    No Clinical Signs, Symptoms or Conditions
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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.