|
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).
|
|
Search Alerts/Recalls
|
|
|