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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
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
SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11776497
MDR Text Key249439770
Report NumberMW5101154
Device Sequence Number3
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  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/04/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
Patient Weight154
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