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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM CGM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Currently have cgm with dexcom. I've had multiple orders that have had a 10 day backorder since switching to the g6. They only allow me to order every 28 days and the sensors are supposed to last 30 for 3. With the 10 day back order we are left without any cgm system, and this has been going on for months. It's not safe and is unacceptable.
 
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Brand NameDEXCOM CGM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key8180584
MDR Text Key131213368
Report NumberMW5082275
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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: 12/18/2018 Patient Sequence Number: 1
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