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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Catalog Number STS-OR-003
Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Defective Device (2588)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/17/2020
Event Type  Injury  
Event Description
I use a dexcom g6 system to monitor my bg for diabetes. Upon recent application of the g6 sensor, the sensor did not release from the applicator. In order to release the applicator from the sensor and then remove from the insertion site, i had to have a family member pry it out using a flat head screwdriver. At that time, it became apparent that part of the sensor that houses the insertion needle had broken off from the rest of the unit and was bent. Upon further inspection of the insertion site, part of the wire that is inserted into the skin had broken off and remained in the arm. Unfortunately, my son is also a type 1 diabetic and just started using the g6 system as well. He has had 4 such similar experiences since he started using the system 2 months ago, leading to great delays in getting replacements and subsequently reverting to using finger sticks for managing his diabetes. There has been no update from the dexcom team regarding these defective products and a pending solution. An additional note: all of the defective supplies were sent by (b)(4). Before changing insurance providers through work in may, all of my supplies came directly from dexcom. In nearly 9 months of ordering directly from dexcom, there were no such instances of defective devices. Fda safety report id# (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10436222
MDR Text Key204189837
Report NumberMW5096162
Device Sequence Number2
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/15/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSTS-OR-003
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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