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

Lot Number 5277362

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

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  Injury  

Event Description

Data from this device, dexcom g6, are used for precise treatment decisions that sustain life.If errant data is used or if data is absent, errant decisions may be made, resulting in too high or too low blood sugars, potential dka, seizures, or even death.We have been using this device for nearly two years, on our son, and have had trouble with getting accurate data from it many times.Sometimes it doesn't give data at all.The tag line for advertisement of this product is "zero finger sticks", and that is anything but accurate.In this particular incident, we replaced our son's dexcom transmitter 30 days ago, and have had errant readings, dropped readings, false lows, jumpiness, signal losses, sensor errors, and had to replace 3 sensors, as well as the transmitter prematurely.We have done many, many finger sticks, and had to give rescue sugar when we normally would not have.We also have given rescue sugar based upon false lows, and sent him high.Our sleep has suffered greatly, as well, and we, his parents, are suffering because of lack of sleep, mental stress, and anxiety over all of this.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR TRANSMITTER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12108104
• MDR Text Key: 260145136
• Report Number: MW5102262
• Device Sequence Number: 4
• 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
• 4 Devices were Involved in the Event: 1 2 3 4

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: 5277362
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 11 YR
• Patient Weight: 32