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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Wheal(s) (2241); Reaction (2414)
Event Date 06/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and waring the adhesive patch might cause infection, bleeding, pain or skin irritations (e. G. ,redness, swelling, bruising, itching, scarring or skin discoloration).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a skin reaction to the adhesive on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. The reaction was located on the abdomen underneath the adhesive and was described as raised, very red, extremely itchy and harder feeling skin. Patient's mother treated the affected area with a prescription antibiotic cream obtained from a non dexcom related event. The date the prescription was obtained is unknown. No additional event or patient information was provided.
 
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Brand NameDEXCOM G5 MOBILE 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 Key5767048
MDR Text Key48710900
Report Number3004753838-2016-03653
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 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/13/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5203875
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 Received06/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2015
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: 07/01/2016 Patient Sequence Number: 1
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