Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 MT20649-2
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver was overheating.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver having overheating could not be determined.A probable cause could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key7804871
MDR Text Key117876052
Report Number3004753838-2018-095763
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-2
Device Catalogue NumberSTR-GL-102
Device Lot Number5200917
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2015
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 Age16 YR
-
-