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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INVASIVE DIABETES MGMT
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DEXCOM INC. G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INVASIVE DIABETES MGMT Back to Search Results
Model Number G6
Device Problem Shipping Damage or Problem (1570)
Patient Problem Hyperglycemia (1905)
Event Date 06/03/2019
Event Type  Injury  
Event Description
Getting my dexcom g6 diabetic supplies from (b)(6) they regularly don't show up and i am stuck with no sensors and or transmitters.In my opinion (b)(6) is causing irreparable damage to diabetics that rely on them for supplies that don't get shipped.I'm stuck with rising blood sugars.Which definitely affects my life expectancy.Please help (b)(6) is causing irreparable harm to diabetics all over the country.This sure seems like a legal issue.Not delivery life saving medicine supplies in time.It's like not being able to get insulin.Please help stop this.Thank you.My blood sugar goes out of control when (b)(6) doesn't send me my management supplies.Fda safety report id# (b)(4).
 
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Brand Name
G6
Type of Device
INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INVASIVE DIABETES MGMT
Manufacturer (Section D)
DEXCOM INC.
MDR Report Key8674544
MDR Text Key147313202
Report NumberMW5087143
Device Sequence Number1
Product Code QDK
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 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG6
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/05/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age55 YR
Patient Weight122
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