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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 Purulent Discharge (1812); Fever (1858); Itching Sensation (1943); Rash (2033)
Event Date 05/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The dexcom g5 mobile continuous glucose monitoring system user's guide states: 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
Patient's mother contacted dexcom on 05/15/2016 to report that the patient experienced a rash and bacterial infection on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Patient's mother stated that the patient had a red and white rash where the adhesive tape was located. Patient had pus coming from their stomach. Patient's stomach was swollen where the adhesive tape was and the area was also very itchy, causing the patient to scratch. On (b)(6) 2016, the patient was taken to urgent care with a fever of 99. 9. It was determined that the patient had a bacterial infection. The patient was treated for 7-10 days. Patient was treated with over-the-counter motrin and kefelx as well as two prescriptions; one ointment for bacterial infection and one for fungus. Additional event or patient information was not 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 Key5707773
MDR Text Key46853856
Report Number3004753838-2016-03409
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 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
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 Received05/16/2016
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: 06/08/2016 Patient Sequence Number: 1
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