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); Invalid Sensing (2293)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 06/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event that occurred on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. The patient stated she started to have a seizure since the cgm did not register her low. It was reported that at the time of the inaccuracy, the cgm read 175mg/dl compared to the bg meter which read 45mg/dl. The patient's husband administered two glucagon injections. Following this, the patient's husband removed the sensor and applied a new one, which the patient said was within the accuracy range. At the time of contact, the patient was stable. Data was evaluated on 07/14/2016. The reported event of cgm inaccuracies was confirmed. A root cause could not be determined. Calibration was not performed after experiencing inaccuracy. The dexcom g5 mobile continuous glucose monitoring system states: if the cgm values are outside the 20/20 range, calibrate again.

• 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: 5801538
• MDR Text Key: 49735392
• Report Number: 3004753838-2016-38792
• 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: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/16/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5207629
• 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: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/17/2016 Patient Sequence Number: 1