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

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

Patient Problem Seizures (2063)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a seizure.The patient's mother reported that the patient was swimming at school.Upon getting out of the pool, the patient experienced a seizure.Nine-one-one (911) was called around 11:00 am and the patient was transported to the hospital emergency room (er) for observation.The patient was given valium for the seizure.The patient was in the hospital for 6 hours and was released to go home the same day.The patient was wearing her dexcom system at the time of event; however, there was no alleged malfunction against the dexcom system.At the time of contact, the patient was at home and felt tired but was doing well.No additional event or patient information is available.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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: 6588014
• MDR Text Key: 75861475
• Report Number: 3004753838-2017-44736
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• 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: 05/10/2017
• 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
• Patient Weight: 77