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

Model Number MT22495

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

Patient Problem Loss of consciousness (2418)

Event Date 03/01/2017

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 90mg/dl compared to bg meter value of 50mg/dl.The patient stated that on (b)(6) 2017 around 9:00pm, he had come home after a basketball game and his cgm was reading 90mg/dl but his bg meter was reading 50mg/dl.The patient stated that he had ate two twinkies, but had passed out before they kicked in.The patient's girlfriend found the patient laying on the floor and called paramedics.The patient was taken to the hospital and was given a glucagon shot by paramedics.The patient does not recall what time he had arrived at hospital, since he was unconscious at the time.The patient does recall that he was there until next day, (b)(6) 2017, until 4:00am.At time of contact the patient's condition was he was at home and well.No additional event or patient information is available.No product was provided for evaluation.The reported event could not be confirmed.A root cause cannot be determined.It was reported that calibration is not performed after experiencing cgm inaccuracies.Labeling indicates: 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.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 6438042
• MDR Text Key: 70968417
• Report Number: 3004753838-2017-23442
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000153
• UDI-Public: (01)10386270000153(241)STK-DR-001(10)5222421
• 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: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5222421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: No
• 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: 68 YR
• Patient Weight: 107