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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 Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016, to report a broken sensor wire occurred on (b)(6) 2016. It was stated that the patient believes a portion of the sensor wire may have broken off and is left under the skin. It was also stated that the insertion site is a little warm. The sensor insertion was at the abdomen on (b)(6) 2016. No additional even to patient information is available.
 
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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 Key5411517
MDR Text Key37519929
Report Number3004753838-2016-05477
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
Report Date 01/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/24/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5203015
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 Received01/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2015
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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