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

Device Problems Unable to Obtain Readings (1516); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2019

Event Type  malfunction  

Event Description

Since i have been upgraded to the dexcom g6, sensors rarely last a 10-day session."no readings" alerts, "sensor failure" alarms, with erratic gaps in readings which are dangerous because i have lost the ability to detect low glucose levels.I have this product because i passed out and broke my leg due to low glucose.I always call dexcom tech support and they usually will send a replacement sensor within 5-7 days.Some techs (with accents hard to understand) make it sound like my fault and sometimes have new instructions, i.E."always rest before inserting sensor", "sometimes it takes 3 hours for the sensor to gather info", and, get this one: "it can't read if your glucose is too high" 'duh,' isn't that what it's supposed to do? when it doesn't read and i don't have any extra sensors, i must set alarms to finger stick level several times during night.Insurance/medicare is strict on rx amounts.Quality control issue? i keep a log now of sensors, lot numbers, and problems/failures.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11010461
• MDR Text Key: 221540959
• Report Number: MW5098340
• Device Sequence Number: 1
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BAYER CONTOUR NEXT GLUCOSE METER; CALCIUM; DEXCOM G6 CGM; KEPPRA; LISINOPRIL; PRAVASTATIN; VIT D
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 40