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-BLU
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted.(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, an error icon was displayed on the receiver.Data was not available for evaluation.Confirmation of the issue and a probable cause could not be determined.No additional event or patient information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key7300374
Report Number3004753838-2018-019396
Device Sequence Number1212410
Product Code MDS
UDI-Device Identifier20386270000099
UDI-Public20386270000099
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/30/2018
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
Operator of Device Lay User/Patient
Device Model NumberMT20649-BLU
Device Catalogue NumberSTK-RX-BLU
Device Lot Number5195048
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2018
Initial Report FDA Received Date02/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age58 YR
-
-