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

Lot Number 5284731

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

My (b)(6) yr old type 1 diabetic uses dexcom g6 cgm since (b)(6) 2020.Ever since (b)(6) 2021 dexcom g6 sensors quality has been terrible.Sensors are not lasting past 3-7 days out of the 10 days advertised by the company.Sensors are constantly giving false lows or reading way higher than actual glucose.There has been so many times where he has been low and we don't catch it unless we are constantly doing finger sticks.The cgm is supposed to eliminate finger sticks but because of how unreliable these sensors have been, i have to constantly be doing finger sticks (at least 10 a day).We go through 300 glucose strips a month.I find this unacceptable if we have a cgm.Every time a sensor starts to give errors or problems it is in the middle of the night between 1-5am.This is causing us to loose so much sleep, we cannot have quality rest at all at nights.Our child cannot even sleep in his own bed because we have to monitor how he sleeps to avoid him laying on the sensor or it causes a false low and eventually a sensor error so he sleeps in bed with us.These issues also cause a lot of absences at school due to rough sleepless nights.All dexcom does is replace sensors.I have had at least 20 sensors replaced in the past 2 months.All lasting between 3-7 days.No explanation why this is happening.No responsibility being assumed at all.Please investigate quality control of these sensors.Please! type 1 diabetes is a forever disease.I can't think patients have to deal with this all of their lives.Especially little ones.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12108312
• MDR Text Key: 260234845
• Report Number: MW5102266
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/29/2021
• 21 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

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: No Information
• Device Lot Number: 5284731
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18