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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 Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Itching Sensation (1943); Swelling (2091); Urticaria (2278); Reaction (2414)
Event Date 09/15/2016
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
Dexcom was made aware on 09/16/2016, that on (b)(6) 2016, the patient experienced a skin reaction. The sensor was inserted into the arm on (b)(6) 2016. Patient stated that they had multiple, small blisters with blood around the sensor adhesive. Reaction was further described as very hot, horribly itchy, swollen and scabbing after a couple of days. Patient also had a 100 degree fever. On (b)(6) 2016, the patient was seen by a healthcare provider. The patient was given an antibiotic injection and advised to apply over-the-counter neosporin to the affected area. Patient reported that the reaction was healing and looked like psoriasis in the shape of the dexcom. Additional patient information is not available. No product or data way returned for investigation. However, a photograph of the reaction was provided for evaluation. The reported event of skin reaction was confirmed. A root cause could not be determined. Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).
 
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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 Key6027897
MDR Text Key57398973
Report Number3004753838-2016-80577
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 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/24/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5214999
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 Received09/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2016
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: 10/13/2016 Patient Sequence Number: 1
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