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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 Problems Detachment Of Device Component (1104); Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Pediatric nurse practitioner contacted dexcom on (b)(6) 2016 to report on behalf of trial patient a detached sensor wire that occurred on (b)(6) 2016. Trial patient was at the clinic to have a new sensor placed and upon removal of the old sensor, the sensor wire was no longer attached to the sensor pod and remained partially imbedded in the patient's arm. Nurse pulled out the sensor wire from the patient's skin. Sensor wire was removed without incident and was intact. No injury or medical intervention was reported. The sensor was inserted into the arm. The dexcom g4 platinum (pediatric) continuous glucose monitoring system user's guide states: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.
 
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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 Key5543014
MDR Text Key41717670
Report Number3004753838-2016-06564
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 03/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2016
Is this an Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2016
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

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