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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 Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/09/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 09/15/2016, that on (b)(6) 2014, the patient experienced a detached sensor wire. Date of issue is an approximation. The sensor was inserted into the upper buttocks. Patient's mother reported that the retained sensor was inserted in the back of the child and resulted in local abscess. About 6 weeks after the event, the wire emerged together with scab tissue and was removed by a nurse practitioner. Removal occurred on (b)(6) 2014. Additional event or patient information was not provided. No product or data was returned for a device evaluation. The reported event of detached sensor wire could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
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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 Key6032083
MDR Text Key57550804
Report Number3004753838-2016-80646
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 09/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2016
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
Device Lot NumberASKU
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 Received10/14/2016
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: 10/15/2016 Patient Sequence Number: 1
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