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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); Rash (2033); Wheal(s) (2241)
Event Date 07/15/2015
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 05/05/2016 to report that the patient experienced a skin reaction on (b)(6) 2015. The reaction was described as red bumps filled with pus and was located where the sensor pod sits on the adhesive. On (b)(6) 2015, the patient was taken to a pediatric after-hours center. The patient was prescribed an antibiotic cream and sent home the same day. Affected area was treated with prescription cream. Additionally, it was reported that the rash dissipated after about a week of use and had not returned as the patient had discontinued use of the cgm system. Patient's mother stated that she believed the patient had developed an allergy to the sensor adhesive/sensor pod. At the time of contact, patient was healthy. 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 Key5697945
MDR Text Key46512516
Report Number3004753838-2016-03254
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 05/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
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 Received05/05/2016
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: 06/03/2016 Patient Sequence Number: 1
Treatment
FLONASE
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