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

Catalog Number SW10611

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 02/16/2017

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 g5 mobile application had intermittent audio output and patient experienced an adverse event. Patient's wife reported that the patient did not hear the low alert. Patient was found having seizures and a blood glucose (bg) of 30 mg/dl. A 911 call was made. Emergency medical technicians (emts) arrived and treated patient with 15 grams of glucose. At time of contact, patient is stable. No additional event or patient information was provided. Data was provided for evaluation. Patient entered a calibration at 04:25am utc. The calibration was not accepted as did not meet the minimum value requirement of >40 mg/dl. Patient had entered 33 mg/dl g5 mobile application responded with a displayed message prompting to enter another bg value. A calibration was successfully entered at 07:35am utc upon which the patient's g5 mobile application displayed a value and audibly gave a low alert. It is between the time of 04:25am utc and 07:35am utc that the patient alleges the adverse event took place, during this time no alert was given for the low glucose due to the g5 mobile application not displaying any values during its request for an additional calibration. The reported no audio alert was confirmed via data. The root cause was determined to be patient misuse/error.

• 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: 6411864
• MDR Text Key: 70170349
• Report Number: 3004753838-2017-15989
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000002
• UDI-Public: (01)00386270000002
• 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: 02/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: SW10611
• 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: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial