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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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/16/2016
Event Type  Injury  
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
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a broken sensor wire. The sensor inserted on (b)(6) 2016. Patient reported that upon removal of the sensor pod, a part of the sensor wire was still attached to the sensor pod and another portion of the sensor wire was left in her skin. On (b)(6) 2016 the patient went to the emergency room (er) to have the sensor wire removed. At the time of contact, the patient was well. No additional event or patient information was provided. No product or data was provided for investigation. The reported event of broken sensor wire could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Two sensor were returned for evaluation. However, it cannot be determined which sensor is the device at fault. A visual inspection was performed on the sensor (serial number (b)(4)/ lot number 5209460) and found that the wire is not broken from the sensor pod and housing puck. The customer's complaint of a broken sensor wire was not confirmed. A root cause could not be determined. A visual inspection was performed on the sensor (serial number (b)(4)/ lot number 5209460) and found that the wire is detached from the sensor pod and housing puck. The customer's complaint of a broken sensor wire was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE 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 Key5947145
MDR Text Key54585513
Report Number3004753838-2016-80344
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5209460(17)170207
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 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/07/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5209460
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 Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2016
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: 09/13/2016 Patient Sequence Number: 1
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