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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 CONTINOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Model Number 9438-06
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Burn(s) (1757)
Event Date 12/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 12/05/2016, that on (b)(6) 2016, the transmitter had abnormal behavior, in addition to an adverse event that occurred. The patient stated that she went to emergency room (er) on (b)(6) 2016 due to transmitter allegedly heating up and burning skin. The affected area was located around the outer edges of where transmitter was placed on left lower of the patient's abdomen. The patient used ice packs on way to er, and once there the patient was given silver sulphate cream. At time of contact the patient was in good condition. A follow up was made by dexcom medical staff stating the patient provided additional images of affected area of skin, which appear to the medical staff to be a possible manifestation of skin reaction to adhesive. The patient denies prior history of skin irritations to dexcom adhesive. No additional event or patient information is available. No product was provided for evaluation. The reported event could not be confirmed. A root cause cannot be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The transmitter (part number stt-gf-001/serial number (b)(4) /lot number 5214249) being used at the time of event was returned for evaluation. A visual inspection was performed an no defects were found. Functional testing and a pairing test was performed and the tests passed. There is no shared data available for review. The customer complaint could not be confirmed with the returned transmitter. A root cause could not be determined. However, it is unknown if this is the complaint device that was returned.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6216740
MDR Text Key63687377
Report Number3004753838-2016-88498
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,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-GF-001
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 Received02/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2016 Patient Sequence Number: 1
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