• 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 GLUCOSE PROGRAM 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 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number SW11786
Device Problem Operating System Version or Upgrade Problem (2997)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that mobile app interruption due to os upgrade on smart device occurred.It was indicated that the operating system for the smart device was not a supported system, which is misuse of the device.Data was received but not investigated as data will not confirm the issue.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G6 GLUCOSE PROGRAM 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 Key16446939
MDR Text Key310288027
Report Number3004753838-2023-044119
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 02/27/2023
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 Catalogue NumberSW11786
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received02/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age75 YR
Patient SexMale
-
-