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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Model Number G6
Device Problems Incorrect, Inadequate or Imprecise Result or 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 Name
DEXCOM G6
Type of Device
INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11776497
MDR Text Key249439770
Report NumberMW5101154
Device Sequence Number1
Product Code QBJ
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  
1 Patient was 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 Lay User/Patient
Device Model NumberG6
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
Patient Weight154
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