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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINOUS GLUCOSE MONITORING SYSTEM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  No Answer Provided  
Event Description
Dear mr. (b)(6): i am concerned about the gg continuous glucose monitor (cgm) reliability that i began using in (b)(6) 2020. I have had 7 incidents, 5 reported to dexcom technical support, since i started using the gg system, resulting in over 33% of the time some part of this gg cgm system failing. Most of the time sensor or calibration errors have been resolved by dexcom tech support telling me to replace the sensor. Here are my problem call: (b)(4) calibration or senor error (replaced sensor),(b)(4) calibration error (replaced sensor), (b)(4) alignment error (do not know what was done), (b)(4) calibration error (replaced sensor), (b)(6) 2021 no call but sensor problem message (replaced sensor), (b)(6) 2021 no call but 'replace sensor' error (replaced sensor 1 day early), (b)(4) no email with case number 'pair transmitter' error (new transmitter and sensor will be sent). I am able to only receive 3 sensors with each request and the errors frequently occur on the third sensor, leaving me with no replacement sensor to use when the third sensor errors out. Without an additional sensor, i am without use of the g6 cgm until the replacement arrives. While tech support indicates the replacement sensor will be mailed "next day delivery", the pickup frequently occurs several days later and i am left without use of the cgm for many days. What is wrong with the g6 components? are the parts from this gg system (sensor, transmitter, insertion device) poorly manufactured? is there no quality assurance program for the manufacturing of the g6 components? this significant error rate did not occur with the dexcom gs. I was a very satisfied user of the dexcom gs system i acquired in 2017 and used until it was discontinued and i could no longer obtain supplies. Or am i doing something wrong with the g6 components? in addition, dexcom's shipping procedures are neither timely nor focused on the customer. The last reported problem, (b)(4) on (b)(6) 2021, required shipping a new transmitter to correct the problem. My call to tech support occurred at 7:00 pm central time on friday, (b)(6) 2021, and i was told a replacement would be sent out with 'next day' delivery. Apparently the 'next day' was supposed to mean monday, (b)(6) 2021, not saturday as i expected and as i was told by the tech support agent. When the transmitter failed to arrive on (b)(6) 2021, i daily called tech support and was told that (b)(6)was unable to pick up the equipment in san diego due to storms in (b)(6). The transmitter was not picked up until friday (b)(6) 2021, and the shipping instructions indicated that the package would be delivered to my residence next day, (b)(6) by 8 pm. As of today, (b)(6) 2021, the package was still in (b)(6). This shipping situation is totally unacceptable: (b)(6) could have delivered a small package with the transmitter well before the thursday date. As an example, i ordered replacement sensors on friday (b)(6) 2021, from (b)(6), one of your distributors. The order was placed about noon and the requested components were shipped via (b)(6), from (b)(6), the same day and were delivered, as promised by (b)(6), on (b)(6) 2021. Why are sensors sent from (b)(6) and transmitters sent from (b)(6)- both are components for the same g6 cgm? why are the components sent from two locations? today, (b)(6), 2021, i called tech support again to determine if a different shipping agent could be used as (b)(6) was not able to provide an estimated date when the package would be received in (b)(6). In talking to tech support, i requested that (b)(6) or (b)(6) be used and was told that only (b)(6) is used for product shipment. Critical medical devices such as the cgm require more than one shipping agent, especially when the primary agent appears to be unable to ship these medical devices in a timely manner. I request a written response to these questions and problems prior to march 15, 2021. In addition to this letter, i am also notifying my doctor, health plan, and the food and drug administration of these problems and issues.
 
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Brand NameDEXCOM G6 CONTINOUS GLUCOSE MONITORING SYSTEM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12294437
MDR Text Key266672577
Report NumberMW5103098
Device Sequence Number3
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/06/2021
7 Devices were Involved in the Event: 1   2   3   4   5   6   7  
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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

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