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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 Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's father contacted dexcom on (b)(6) 2015, to report use of lidocaine for sensor site skin preparation on (b)(6) 2015. Sensor was inserted at the abdomen on (b)(6) 2015. Patient's father reported that use of lidocaine was not specifically for dexcom use. Patient's father uses lidocaine as a preventative measure. Patient's father reported using lidocaine for years. Patient's father further reported that he applies lidocaine to sensor insertion site routinely prior to sensor insertion. Additionally, patient's father rubs off the lidocaine with a cloth, then wipes the skin and transmitter down with an alcohol swab prior to sensor insertion. Date of medical intervention is unknown. No additional event or patient information is available. There was no reported alleged device malfunction. It should be noted that the dexcom g5 mobile continuous glucose monitoring system 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). Additionally, it should be noted that the dexcom g5 mobile continuous glucose monitoring system states: before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow to dry. This may help prevent infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better. Make sure there are no traces of lotions, perfumes or medications on the area.
 
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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 Key5365237
MDR Text Key35920864
Report Number3004753838-2016-00429
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 12/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5205253
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 Received12/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2015
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: 01/13/2016 Patient Sequence Number: 1
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