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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

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DEXCOM, INC. DEXCOM G5 MOBILE 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 05/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The dexcom g5 mobile continuous glucose monitoring system user's guide states: on rare occasions, the sensor wire may break or detach from the sensor pod. If a sensor wire breaks under the skin with no portion of it visible, don't remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016, to report a detached sensor wire that occurred on (b)(6) 2016. The sensor insertion was at the arm on the (b)(6) 2016. The dexcom g5 mobile continuous glucose monitoring system user's guide states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly. Patient stated the ware was in the skin. There was no report any injury or medical intervention. No additional event or patient information is available.
 
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Brand NameDEXCOM G5 MOBILE 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 Key5686850
MDR Text Key46165353
Report Number3004753838-2016-08233
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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 05/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2016
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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