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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Rash (2033); Wheal(s) (2241); Reaction (2414)
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e. G. , redness, swelling, bruising, itching, scarring or skin discoloration).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that beginning on approximately (b)(6) 2016, the patient experienced multiple skin reactions. Sensors were inserted into the abdomen. The patient¿s father stated that skin reactions occurred with every sensor the patient used. Exact incident dates were unknown, however the patient¿s father estimated that the last sensor was inserted in early (b)(6) 2016. Approximately 2-3 days after wearing a sensor, the patient experienced a gross rash with scabs and red, raised welts or bumps. The skin reaction was located on the middle of the abdominal area and treated with benadryl. Patient¿s father indicated that they had tried their doctor¿s suggestions to alleviate the issue, however the date of medical intervention was not provided. At the time of contact, it was indicated that the patient was fine. No additional event or patient information is available.
 
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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 Key7782940
MDR Text Key117130734
Report Number3004753838-2018-092063
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 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/14/2018 Patient Sequence Number: 1
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