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

Model Number 9500-35

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Weakness (2145)

Event Date 01/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Distributor contacted dexcom on behalf of patient 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.Sensor was inserted on (b)(6) 2016.It was reported that after breakfast, the patient decided to going for a one hour brisk walk.The patient's bg level was around 9mmol/l and she lowered her total basal insulin dosage (tbd) prior to her walk.After about 10 minutes, the receiver showed a single arrow and then a double arrow.The patient reported that the receiver displayed increasing values from 10.3mmol/l to 11.16mmol/l to 15.3mmol/l.Shortly after, the patient then turned off her tbd, took a small bolus dose, and saw that the receiver displayed 17mmol/l.After 40 minutes, the cgm continued to stay at 17mmol/l and the patient thought it was strange that her bg level had not dropped.The patient thought it may have been contributed to the fact that she took too small of a bolus dosage and that she had a cold.About 2 minutes after, the cgm displayed the error reading symbol and knew something was wrong.The patient began to feel weak in her legs, but arrived home about 5 minutes later.She checked her bg level with a bg meter and it displayed 2.9mmol/l, so she got something to eat and then felt better.No additional event information or medical intervention was reported.

Manufacturer Narrative

(b)(4).

• 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: 5455990
• MDR Text Key: 38853381
• Report Number: 3004753838-2016-25422
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• 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: 55 YR