MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE

Model Number DEXCOM G6

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

No monitor of my blood sugar; i replaced my dexcom 6 sensor and transmitter at 6 am on (b)(6) 2021. I waited the 2 hour warm up period. Then waited an additional 2 hours. I got a signal loss error. I called dexcom, they had me replace the sensor, they said they will ship me a new sensor 3-5 days (b)(6). I replaced the sensor waited 2 more hours and an additional 2 hours. Still signal loss. I called dexcom again. Now it has been close to 24 hours since i had eaten (i don't have testing strips any more) dexcom's advertising says you don't need them any more. Again they agreed to send me another sensor and new transmitter, again 3-5 days (b)(6). When i asked what happens if my blood sugar crashes and i end up in the er, who is going to pay for er visit. When i asked for operators name, i was told that he could not give it to me. When i asked to speak to a manager, i was put on for over 2 hours and was told the manager would return my call, that was at 7 pm on (b)(6) 2021 it is now (b)(6) 2021 and i am still waiting for a return call. Dexcom could not (b)(6) over night and the best they could do was 3-5 days (b)(6). I had to purchase a new test kit to check my blood sugars until the dexcom replacement shows up. They claim that they will email me a (b)(6) tracking number, here it is 2 days later and still don't have an email with a tracking number even though they confirmed my email address. Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12106800
• MDR Text Key: 260072283
• Report Number: MW5102231
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/27/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: DEXCOM G6
• Device Lot Number: 5285086
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 07/01/2021 Patient Sequence Number: 1