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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM 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 Itching Sensation (1943); Wheal(s) (2241); Reaction (2414)
Event Date 06/19/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). The dexcom g4 platinum 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
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2015, the patient experienced a skin reaction. The sensor was inserted into the abdomen on (b)(6) 2015. Patient described the reaction as a small, itchy welt located at the insertion site. On (b)(6) 2015, the patient removed the sensor. On (b)(6) 2016, dexcom received additional information regarding the patient's reaction. It was reported that the patient had a skin allergy to the wire, and had to stop using the dexcom device. It was determined that the patient was allergic to silver nitrate. Additionally, it was indicated that the patient only uses the dexcom device for a day periodically, and that their health care provider was made aware of the issue. Patient's healthcare provider was possibly made aware of the issue in (b)(6) 2015. No additional event or patient information is available. No product or data was returned for evaluation. The reported event of skin reaction could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key6012863
MDR Text Key56910705
Report Number3004753838-2016-80462
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 09/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/07/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5200940
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 Received09/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2015
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: 10/07/2016 Patient Sequence Number: 1
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