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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 Problem Skin Inflammation (2443)
Event Date 10/09/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016, to report that the patient experienced a skin reaction on the left side of the abdomen, on (b)(6) 2015. Sensor was inserted at the abdomen on (b)(6) 2015. Patient's mother described the skin reaction as raised skin at the sensor insertion site. Patient's mother stated that all insertions since (b)(6) 2015 are visible. Patient was hospitalized on (b)(6) 2015 not related to dexcom products when the physician noticed the spots on the patient's body. The physician examined the present spots on the body from sensor insertions and recommended that the patient use clorox water to bathe and betadine to clean the skin prior to insertions. At the time of contact, patient's mother reported that the patient still had spots present. No additional event or patient information is available. It should be noted that the dexcom g5 mobile 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).
 
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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 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 Key5450753
MDR Text Key38659237
Report Number3004753838-2016-01190
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 01/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
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
Device Lot NumberASKU
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 Received01/26/2016
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: 02/22/2016 Patient Sequence Number: 1
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