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

Model Number MT20649-1

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted: (b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver initialized without a manual restart.No additional event or patient information is available.No product or data were provided for evaluation.The report of the receiver initializing without manual restart could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Upon further review, this record has been determined to not be reportable based on confirmation that this was a duplicate of a non-reportable record.Please disregard initial reporting under mfr# 3004753838-2018-152106.

• 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: 8136185
• MDR Text Key: 129498299
• Report Number: 3004753838-2018-152106
• 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: 11/10/2018

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: MT20649-1
• Device Catalogue Number: STR-GL-004
• Device Lot Number: 5224380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: 78 YR
• Patient Weight: 65