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

Model Number 9445-02

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a pairing failure occurred.Data was evaluated and the allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss was determined to be that the transmitter and app were unable to establish a connection.The reported event of a pairing failure is reportable based on the finding of the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a pairing failure occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage check was performed and failed.A review of the share logs was performed and a pairing failure was found within the investigation window.The allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss was determined to be that the transmitter and app were unable to establish a connection.The reported event of a pairing failure is reportable based on the finding of the transmitter and app were unable to establish a connection.

• 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
• MDR Report Key: 10767586
• MDR Text Key: 214111617
• Report Number: 3004753838-2020-128593
• Device Sequence Number: 1
• Product Code: QBJ
• UDI-Device Identifier: 00386270000385
• UDI-Public: 00386270000385
• Combination Product (y/n): N
• PMA/PMN Number: DEN170088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9445-02
• Device Catalogue Number: STT-OR-001
• Device Lot Number: 5273516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR