MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problem Seizures (2063)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2016 that on(b)(6) 2016, that the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event. The sensor was inserted at the abdomen on (b)(6) 2016. Patient reported she had a seizure between 5:30 and 6:30 am. At that time, the patient's cgm was reading 167mg/dl. Patient did not take a finder stick (fs) reading. Patient self-treated by taking ten (10) glucose tablets to bring her bring her blood glucose (bg) level back. At the time of contact, patient is good. No additional event or patient information is available. No product or data was provided for evaluation. The customer complaint could not be confirmed. A root cause could not be determined. It was reported that the patient did not calibrate after experiencing inaccuracy. It should be noted that the dexcom g4 platinum continuous glucose monitoring system user's guide states: if the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, wash your hands and take another blood glucose measurement. If the difference between this second blood glucose measurement and the sensor is still greater than 20% for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, recalibrate your sensor using the second blood glucose value. The sensor glucose reading will correct over the next 15 minutes. It was reported that the same bg meter was not used throughout the same sensor session. The dexcom g4 platinum continuous glucose monitoring system user's guide states: use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your meter in the middle of a sensor session. Blood glucose meter and strip accuracy vary between blood glucose meter brands.

• Brand Name: DEXCOM G4 PLATINUM 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: 6031994
• MDR Text Key: 57552309
• Report Number: 3004753838-2016-80582
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• 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
• Device Lot Number: ASKU
• 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: 09/19/2016
• 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: 10/15/2016 Patient Sequence Number: 1