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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/19/2021
Event Type  malfunction  
Event Description
Unable to get cgm readings; i am a (b)(6) male diabetic. I have used dexcom continuous glucose monitors for several years now. Currently i use a dexcom g6 system. I have had two g6 transmitters fail within the past 2 weeks. I contacted dexcom and they informed me that my transmitter had "expired" and that is why i received a "transmitter error" message on my monitor. They requested that i provide them the dates on the transmitter box. When i read them the dates, they ask me to describe the icons next to the dates. Note: no where on the box is the term "expiration date" printed. Until now, i was not even aware that there was an expiration date. They informed me that the first date shown on the box (they describe the icon as a building) is the date the product leaves dexcom and the second date (they describe that icon as an hour glass) is the final date that the transmitter can be "in use" after insertion. They then informed me that the sensor expires 5 months from the first date. No where is that printed on the packaging. Since i had one new transmitter left, from a recent rx at my (b)(6), i was about to insert that so i could finally get my blood glucose readings. Before doing that i examined the sealed box and i informed the rep that the first date (building icon) was 09-01-2020 and the second date (hour glass) 09-01-2021. I also explained that the (b)(6) rx tag was still on the box and it showed the date the rx was filled as (b)(6) 2021 and that the product should be used by 3/2/2022. I pointed out that, based on what i was being told by dexcom, the transmitter in the sealed box, which i had picked up from (b)(6) on (b)(6) 2021 or later, had expired on 2/1/2021. The rep confirmed that i was correct & that the transmitter had expired more than one month before the rx had been filled. I was told that this was not a dexcom problem but that i should return it to (b)(6) and request that it be replaced with a fresh product. Since the rx labels affixed to the products by (b)(6) show a "use by date" that is one year from the rx fill date, i doubt (b)(6) is aware of this extremely important fact. Before concluding this call, and since i had a box of dexcom g6 sensors handy, i examined that box and informed the dexcom representative that the dates on that box were as follows: first date (building icon) 10/10/2020 and second date (hourglass icon) 10-20-2021. In response i was informed that since they were sensors and not transmitters, the dates really were meaningless and that they don't expire for two year. How's that for consistency! i had been away for a week and had taken sufficient dexcom supplies with me, and extra supplies as well, in case something malfunctioned, which has happened on occasion. Because of the sensor failure that occurred during this period, i was without cgm capability for the last few days of my trip. I contacted dexcom as soon as i returned home and after i had inserted a new transmitter (which also failed). I now await dexcom shipping 1 transmitter to me so that i can resume continuous glucose monitoring. I am quite disturbed about this and i feel the explanations provided were nonsense. I consider myself to be reasonably cognizant, and in the years i've been using these products i was never aware there were expiration dates to be considered. I told the representative that i suspect most older patients who use dexcom products would probably respond in the same way. There is something inherently wrong with dexcom being permitted to label their products in such a way, as to cause confusion & doubt as to whether their products actually do expire. An expensive product that "expires" should be clearly and boldly marked as such. I believe dexcom is guilty of misrepresenting their products & i feel the fda should take action, as this practice causes serious safety issues. Fda safety report id# (b)(4).
 
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Brand NameSENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12050378
MDR Text Key258330078
Report NumberMW5102052
Device Sequence Number4
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 06/20/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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

Patient Treatment Data
Date Received: 06/22/2021 Patient Sequence Number: 1
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