MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT24078

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver initialized without a manual restart.No additional event or patient information is available.The device has been received for investigation.A follow-up will be submitted upon completion of device investigation.

Manufacturer Narrative

Com-(b)(4).

Event Description

The complaint device was returned for evaluation.An external visual inspection was performed and no defects were found.The receiver was charged and would perpetually reboot.Receiver functional tester: passed all relevant testing.The receiver download was retrieved and no issues were found in the investigation window.The reported event of initializing screen without manual restart was undetermined.A probable cause could not be determined.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7916344
• MDR Text Key: 122341007
• Report Number: 3004753838-2018-114863
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000583
• UDI-Public: 00386270000583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT24078
• Device Catalogue Number: STK-OR-001
• Device Lot Number: 5239457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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: 75 YR