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

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

Patient Problems Seizures (2063); Loss of consciousness (2418)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an adverse event. The certified diabetes educator (cde) reported that they patient met with the patient at the doctor's office on (b)(6) 2017 regarding health insurance information for a trial device. On (b)(6) 2017, the cde checked in with the patient and was informed that the patient had spent the night in the emergency room (er) on (b)(6) 2017. The patient stated that the event involved his blood sugar and thinks that he had seizures. The patient further stated that he was out cold when the event happened. Additionally, it was indicated that at the time of contact, the patient was still wearing the dexcom system but there was no allegation against the trial device. No additional patient or event information is available. Data was provided for evaluation. There was no allegation against the cgm that was reported, although the patient was wearing the system on the incident date. Data investigation of the patient's studio data was conducted to review events on the date of incident. A review of patient's diagnostic charts shows that the patient experienced estimated glucose values below 50 mg/dl and egvs over 375 mg/dl. No root cause to be determined as there was no allegation against the system.

• 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: 6969006
• MDR Text Key: 89980599
• Report Number: 3004753838-2017-94203
• 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: health professional,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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?: No
• Event Location: No Information
• Date Manufacturer Received: 09/26/2017
• 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: 10/23/2017 Patient Sequence Number: 1