• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9445-24
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2023
Event Type  malfunction  
Event Description
It was reported that signal loss over one hour 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.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key16546391
MDR Text Key311324824
Report Number3004753838-2023-056716
Device Sequence Number1
Product Code QDK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K182041¿
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2023
Device Model Number9445-24
Device Catalogue NumberSTT-OM-001
Device Lot NumberP13302354
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age71 YR
Patient SexFemale
Patient Weight106 KG
-
-