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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  Injury  
Event Description
First, dexcom has multiple problems with the g6 system. If you look at the fb group you will see a plethora of failures happening daily. This seems to fall within the warranty of merchantability. Today's problem is 2 fold; failed transmitter and failed sensor. Installed a new transmitter and sensor today. Initially the sensor failed to retain the transmitter which rendered the sensor useless. After replacing the sensor the new transmitter won't connect via bluetooth. I tried all conventional bluetooth resolutions but none fixed the problem. This product (g6) needs to have a recall issued until potentially life threatening problems are resolved. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12532664
MDR Text Key273648550
Report NumberMW5104208
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/23/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number5293710
Was Device Available for Evaluation? Yes
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: 09/24/2021 Patient Sequence Number: 1
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