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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report a detached sensor wire that occurred on (b)(6) 2015. The sensor was inserted into the abdomen. Patient stated that upon removal of the sensor pod the sensor wire remained under their skin. Patient went to the doctor and had x-rays taken. Doctor stated that the sensor wire was coiled up and posed no threat or danger to him. Patient decided to leave sensor wire in the body. Patient could not recall the date of the doctor's visit. No additional event or patient information was provided. The complaint device was returned for evaluation. A follow-up report will be submitted upon completion of evaluation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The sensor was inserted into the thigh.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5582762
MDR Text Key42848207
Report Number3004753838-2016-02348
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 03/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/12/2014
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5086137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2013
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: 04/15/2016 Patient Sequence Number: 1
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