• 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 MDS

  • 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 MDS Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Rash (2033); Scarring (2061); Skin Inflammation (2443)
Event Date 12/14/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's father contacted dexcom on (b)(6) 2016, to report that the patient experienced a skin reaction at sensor adhesive site, which occurred on (b)(6) 2015. Sensor was inserted at the arm on (b)(6) 2015. Patient's father reported that the skin gets discharge, irritated, itchy and red where the white adhesive sits on the skin. Additionally, patient's father reported that the patient experienced minimal scarring to the affected area. Patient's father treats the reported skin reaction with over the counter (otc) hydrocortisone spray. No additional event or patient information is available. It should be noted that the dexcom g4 platinum continuous glucose monitoring system users guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring, or skin discoloration). Additionally, it was reported that the sensor was inserted at the arm. It should be noted that the dexcom g4 platinum continuous glucose monitoring system users guide states: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5441578
MDR Text Key38342979
Report Number3004753838-2016-01047
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,Followup
Report Date 01/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/04/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5205373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/17/2016 Patient Sequence Number: 1
-
-