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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known contributor of hypoglycemia and seizures.

Event Description

Patient contacted dexcom on 01/03/2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and a hypoglycemic event that occurred on (b)(6) 2015.Sensor was inserted on (b)(6) 2015.On (b)(6) 2015 at around 6:00pm, the patient was having dinner with his family when he experienced low blood glucose and had a seizure.Paramedics were called and arrived between 6:30pm and 7:00pm and treated the patient with dextrose 50% intravenously.Patient reported that at that time he woke up, went home with his family, and recovered at home.At the time of contact, the patient stated he was okay, but nervous.No additional event information was reported.It was reported that calibration was not performed after experiencing inaccuracies.The dexcom g5 mobile continuous glucose monitoring system user's guide states: if the cgm values are outside the 20/20 range, calibrate again.The receiver data log was reviewed on 01/20/2016.The complaint of inaccurate cgm values was confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).Describe event of problem - correction to remove statement "it was reported that calibration was not performed after experiencing inaccuracies.The dexcom g5 mobile continuous glucose monitoring system user's guide states: if the cgm values are outside the 20/20 range, calibrate again.The receiver data log was reviewed on 01/20/2016.The complaint of inaccurate cgm values was confirmed.A root cause could not be determined.".

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, the complaint sensor was not returned to dexcom.The transmitter (part number stt-gf-001/serial number (b)(4)/lot number 5208121), being used with the complaint sensor, was returned on (b)(6) 2016.The returned transmitter was visually inspected and no defect was found.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.The device was determined to be operating within the required specifications without malfunction.The reported event of inaccuracies was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5390601
• MDR Text Key: 36817658
• Report Number: 3004753838-2016-10234
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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,Followup,Followup
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• 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: 53 YR
• Patient Weight: 86