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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
Model Number G6
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Sensing Problem (2917)
Patient Problem Insufficient Information (4580)
Event Date 04/30/2021
Event Type  malfunction  
Event Description
I have the dexcom g6 glucose meter. I have had repeated sensor problems and have reported it to the company on multiple occasions. Approximately 1 out of every 3 sensors are dangerously off on their reading. Last night the reported blood sugar was 40 points higher than the finger stick blood meter. This morning it was almost 50 points low. I have repeatedly calibrated this device with no success. I reported this problem to the company (for about the 5th time) but they don't seem to be taking it seriously. If any patient bases their insulin decisions on this meter, they may be injured or die. Fda safety report id # (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11776497
MDR Text Key249439770
Report NumberMW5101154
Device Sequence Number2
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 04/30/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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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