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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number STS-OR
Device Problems Break (1069); Entrapment of Device (1212); Obstruction of Flow (2423); Communication or Transmission Problem (2896); Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); Implant Pain (4561)
Event Date 07/18/2021
Event Type  Injury  
Event Description
Was inserting a dexcom g6 cgm into my right abdomen. [lot#: 5291584 ref#: (b)(4)] the applicator produced the distinguishable click sound as the insertion needle is plunged into the skin and produced the secondary click that indicates the insertion needle has been retracted and the applicator can be removed. However, the insertion caused me intense pain and throughout the night i would experience pain if any pressure were placed on the site. The transmitter failed to connect over night. Upon removal the following morning i discovered the insertion needle had been detached from the applicator and has been left inside me over night. The insertion needle was also causing the catheter that transports the blood to the transmitter to be blocked and occluded causing a pairing failure to the new transmitter. This batch of sensor applicators was sent to me by dexcom customer support advised as "a remanufactured lot of applicators" to fix a previous issue of the insertion device and insertion needle mechanically binding during insertion causing a failure in the release mechanism of the hand held inserter as well as a failure in the insertion needle retraction mechanism. The sensor of issue in this report was a replacement lot for a preexisting issue, only to cause an even worse issue of leaving an exposed needle inside the patient until they remove the site due to the insertion needle breaking from the inserter during insertion. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12203474
MDR Text Key262994013
Report NumberMW5102668
Device Sequence Number1
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 07/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTS-OR
Device Lot Number5291584
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: 07/20/2021 Patient Sequence Number: 1
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