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

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).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11776497
• MDR Text Key: 249439770
• Report Number: MW5101154
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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
• Device Model Number: G6
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 154