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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 Problem Component Missing (2306)
Patient Problems Increased Sensitivity (2065); Foreign Body In Patient (2687)
Event Date 04/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's father contacted dexcom on (b)(6) 2016 to report a missing sensor wire that occurred on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Upon removal of the sensor pod, the sensor wire was not visible from the bottom side of the sensor pod. The sensor wire was also not visible in the patient's skin, however, the insertion site had a bump, causing the patient's parent's to believe the sensor wire was retained inside. Patient also experienced tenderness at the insertion site. Patient's mother stated that they called their endocrinologist for advice and were advised to monitor the site. At the time of contact, the patient was fine. No additional event or patient information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Two sensors (serial number (b)(4)) were returned for evaluation. Both devices were visually inspected. The sensor wire for (b)(4) was missing from the sensor pod and housing puck. The sensor wire from (b)(4) was detached from the housing puck. The reported event of a missing sensor wire was confirmed; however, it is unknown which of the two devices were the complaint device. A root cause could not be determined.
 
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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 Key5626498
MDR Text Key44265098
Report Number3004753838-2016-02617
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,Followup
Report Date 04/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/19/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5207495
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 Received08/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
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: 05/03/2016 Patient Sequence Number: 1
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