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

Catalog Number SW10611

Device Problem Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 03/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report a loss of connection and an adverse event that occurred on (b)(6) 2016. Patient's device was showing signal loss and during that time, he had a hypoglycemic seizure. Patient also experienced loss of consciousness. During the time of the event, the patient was at a restaurant with his wife and the paramedics were called. The patient was taken to the hospital and placed on an iv. Patient was at the hospital for about 3 hours and was discharged. Patient stated that when he got out of the hospital the device was working again. At the time of contact, the patient reported having headaches, cramps in the legs and being mentally fuzzy.

Manufacturer Narrative

(b)(4) describe event or problem - additional, additional information, event problem and evaluation codes - additional.

Event Description

Data was received from the patient. A review of the data log confirmed the reported event of a loss of connection. A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5610222
• MDR Text Key: 43713167
• Report Number: 3004753838-2016-02810
• Device Sequence Number: 1
• Product Code: MDS
• 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,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SW10611
• 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 Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/26/2016 Patient Sequence Number: 1