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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 9500-35
Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Distributor contacted dexcom on (b)(6) 2016 to report on behalf of patient a detached sensor wire that occurred on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Nurse removed sensor wire from the patient and upon its removal, did not see the sensor wire attached to the sensor pod. Nurse thought she did something incorrectly and inserted a new sensor. On (b)(6) 2016, about one month after the first sensor insertion, the patient went into the hospital for a consultation and a nurse realized there was a mass under the patient's skin. Patient did not have any symptoms and the skin was not red or inflamed. The doctor performed an ultrasound which confirmed the wire filament placed under the skin. As of (b)(6) 2016 the sensor wire had not been removed. No additional event or patient information was provided. The patient using the device is under two years old. The dexcom g4 platinum continuous glucose monitoring system states: the dexcom g4 platinum continuous glucose monitoring (cgm) system is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes.
 
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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 Key5546505
MDR Text Key41817567
Report Number3004753838-2016-25949
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/24/2016
Device Model Number9500-35
Device Catalogue NumberSTS-GL-005
Device Lot Number5203871
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 Received03/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2015
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: 04/04/2016 Patient Sequence Number: 1
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