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

Model Number MT20649-2

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver had intermittent vibration.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of intermittent vibration could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.The device was visually inspected and it passed.The receiver was charged and rebooted.The log was downloaded and reviewed finding no errors related to the complaint."try it" manual tests were performed and passed.Functional testing was performed and the and it passed.The receiver case was opened for an internal visual inspection and it passed.The vibrator motor resistance was measured and it registered within specification.The allegation was not confirmed.The 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: ying chen ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8136199
• MDR Text Key: 129492726
• Report Number: 3004753838-2018-152119
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-2
• Device Catalogue Number: STK-GL-108
• Device Lot Number: 5222676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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 Age: 62 YR