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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC. DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Model Number DEXCOM G6
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Event Description
No monitor of my blood sugar; i replaced my dexcom 6 sensor and transmitter at 6 am on (b)(6) 2021. I waited the 2 hour warm up period. Then waited an additional 2 hours. I got a signal loss error. I called dexcom, they had me replace the sensor, they said they will ship me a new sensor 3-5 days (b)(6). I replaced the sensor waited 2 more hours and an additional 2 hours. Still signal loss. I called dexcom again. Now it has been close to 24 hours since i had eaten (i don't have testing strips any more) dexcom's advertising says you don't need them any more. Again they agreed to send me another sensor and new transmitter, again 3-5 days (b)(6). When i asked what happens if my blood sugar crashes and i end up in the er, who is going to pay for er visit. When i asked for operators name, i was told that he could not give it to me. When i asked to speak to a manager, i was put on for over 2 hours and was told the manager would return my call, that was at 7 pm on (b)(6) 2021 it is now (b)(6) 2021 and i am still waiting for a return call. Dexcom could not (b)(6) over night and the best they could do was 3-5 days (b)(6). I had to purchase a new test kit to check my blood sugars until the dexcom replacement shows up. They claim that they will email me a (b)(6) tracking number, here it is 2 days later and still don't have an email with a tracking number even though they confirmed my email address. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12106800
MDR Text Key260072283
Report NumberMW5102231
Device Sequence Number3
Product Code QBJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/27/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXCOM G6
Device Lot Number5285086
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: 07/01/2021 Patient Sequence Number: 1
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