MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; CONTINOUS GLUCOSE MONITOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Loss of consciousness (2418)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of loss of consciousness and nausea.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient passed out during sensor placement.The patient stated that during the placement of sensor she got light headed and felt like she was going to throw up a bit and then passed out for a couple of minutes.The patient stated that she checked her blood glucose (bg) levels and she was about 300, which is fairly normal for her.As of now she thinks it might have been her anxiety getting the best of her.She has since applied another sensor and had no issues.No allegation was made against dexcom products.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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 Key: 6174880
• MDR Text Key: 62418360
• Report Number: 3004753838-2016-88483
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NA(241)NA(10)NA(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR