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

Model Number MT22719-PNK

Device Problem Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 04/15/2017

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 loss of connection between transmitter and receiver, a hypoglycemic event, and seizure. Patient's husband called an ambulance at 3:40 am due to the seizure and low blood glucose (bg). Paramedics arrived at 3:50 am. Patient's bg value was at 31 mg/dl. Patient arrived at hospital and was treated with a glucagon shot and a sandwich. Patient left hospital at 5:00 am when she was stable. At the time of contact, patient is good. No additional patient or event information was provided. No product or data was provided for investigation. The reported event could not be confirmed. The root cause could not be determined.

• 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: 6575863
• MDR Text Key: 75460458
• Report Number: 3004753838-2017-26499
• 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

• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MT22719-PNK
• Device Catalogue Number: STR-GF-PNK
• Device Lot Number: 5221991
• 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: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• 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: 05/18/2017 Patient Sequence Number: 1