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 Stroke/CVA (1770)

Event Date 03/10/2017

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 stroke. At the time of the event, the patient consulted with his endocrinologist who, based on data from the clarity data management tool, dismissed the idea that the stroke was due to the patient's diabetes or his use of the dexcom system. The patient's endocrinologist particularly based this assessment on the provided a1c estimate in clarity. After the event, the patient had an a1c blood lab test performed, and the result, 9. 1, was much higher than the estimated a1c value in clarity, 7. 4. After the blood test, the patient's endocrinologist indicated that the stroke was related to the patient's diabetes, which he believed was not well-controlled due to the a1c estimation given in clarity. At the time of contact, the patient had recovered from the stroke. The patient did not provide any additional event information. A review of clarity data was performed and the estimated a1c was 8. 2. The reported event of stroke due to diabetes was not confirmed. A root cause could not be determined. Dexcom labeling indicates: caution- the [clarity] software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.

• 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: 6474275
• MDR Text Key: 72172470
• Report Number: 3004753838-2017-26270
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/07/2017 Patient Sequence Number: 1