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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 02/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on 03/14/2016 to report a detached sensor wire that occurred on (b)(6) 2016. The sensor was inserted into the arm on (b)(6) 2016. Patient's mother stated that the sensor wire was not attached to the sensor pod or to the skin upon its removal. On 03/14/2016 patient's mother spoke to dexcom's doctor and reported that she believed the sensor wire was embedded in the body as the patient did not see the wire when the sensor pod was removed. However, patient did not have any discomfort or pain and the sensor wire was not visible under the skin. No further medical attention was sought. Additional event information was not provided.
 
Manufacturer Narrative
(b)(4).
 
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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 Key5572607
MDR Text Key42489817
Report Number3004753838-2016-06869
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 03/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
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 Received04/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/12/2016 Patient Sequence Number: 1
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