MAUDE Adverse Event Report: DEXCOM, INC. UNKNOWN MDS

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problem Seizures (2063)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Diabetes mellitus is a known cause of seizures.

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event on (b)(6) 2016. The date of the event is an approximation. Patient's mother reported the patient had a seizure while sleeping at her home. Patient's mother checked patient's receiver and the patient's blood glucose (bg) was 150 points different from his glucometer. Patient's mother stated that he apparently had not calibrated the device like he needed to. Patient's mother stated that she worked with him and was able to bring the devices closer to accuracy. Patient's mother stated that the patient suffered from low blood sugar seizures, and most likely had 500 plus seizures over his life span mostly as a young adult. No additional patient or event information was provided.

• Brand Name: UNKNOWN
• 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: 5766678
• MDR Text Key: 48711268
• Report Number: 3004753838-2016-13074
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 07/01/2016 Patient Sequence Number: 1