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

Model Number 9500-27

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

Patient Problem Loss of consciousness (2418)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the continuous glucose monitor (cgm) had inaccuracies compared to blood glucose (bg) meter in addition to an adverse event that occurred.The sensor was inserted in the patient's abdomen on (b)(6) 2017.The patient reported that cgm displayed value of 5mmol/l compared to bg meter value of 2.8mmol/l.The patient stated that she had fallen unconscious for around 20 minutes.An ambulance was called and paramedics attended.The patient's children provided dextrose to the patient prior to the arrival of the paramedics which helped her recover.The patient was not taken to hospital.At time of contact the patient's condition was fine.No additional event or patient information is available.It was reported that the sensor was worn beyond seven days.Labeling indicates: your sensor gives you sensor glucose readings for up to seven days.The performance of a sensor has not been tested beyond seven days.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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: 6455603
• MDR Text Key: 71576416
• Report Number: 3004753838-2017-14933
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GF-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 73