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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE 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); Unspecified Infection (1930); Swelling (2091)
Event Date 01/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The user's 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). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on 04/29/2017 that on (b)(6) 2017, the patient experienced a skin reaction. The date of issue is an approximation. The sensor was inserted in the abdomen on (b)(6) 2017. The reaction was located on the abdomen next to the belly button. After the full 7 days of wearing the sensor, the patient stated that the sensor was uncomfortable. Upon removing the sensor, the patient noticed a little bump. The next day, the sensor insertion site was swollen, red and was hot to touch. The redness had spread from the abdomen to the groin area. On (b)(6) 2017, the patient saw their physician and was prescribed antibiotics to allow the infection to clear. At the time of contact, the patient was doing fine. No additional event or patient information is available.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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 Key6585660
MDR Text Key75778213
Report Number3004753838-2017-40274
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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 04/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2017
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: 05/23/2017 Patient Sequence Number: 1
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