• 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 G4 PLATINUM 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 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22608
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver ceased to function. No product or data was provided for evaluation. Confirmation of 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 NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8695441
MDR Text Key148464357
Report Number3004753838-2019-048320
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22608
Device Catalogue NumberSTK-PR-001
Device Lot Number5233479
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-