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

Model Number MT20649-1

Device Problem Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted at the abdomen.No additional event or patient information is available.No product or data was provided for evaluation.The reported inaccuracy could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and there was no failure detected related to the complaint.The data log was reviewed and inaccuracies were observed.The reported event of inaccurate cgm values was confirmed during log review.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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: 6832739
• MDR Text Key: 84093871
• Report Number: 3004753838-2017-55953
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STK-GL-013
• Device Lot Number: 5214906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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