Charge 5: ECG False Positives

[EJNIV]

While the disclaimer is clear that the Charge 5 ECG is NOT a medical device, starting on 11/2/23 it stopped recording sleep data indicating "Your tracker couldn't get a consistent heart-rate reading while you slept."  I have had benigh PVCs for 20 years with normal treadmill and regular EKG tests.  However, the Charge 5 ECG kept suggesting Afib, and that concerned me.

I had a follow-up appointment with my cardiologist and wore the Biotel (Phillips) ECG device for 30 days.  No evidence of Afib.  I purchased the EMAY portable ECG monitor (EMG-20) and have been using it over the last week.  (LOVE the EMAY!)  This morning the Charge 5 indicated Afib.  Used the EMAY immediately that only captured usual irregular heart beat.

I share this in hopes that when Charge 6 comes out it will be better equipped to discern irregular HR vs. Afib.  My cardiologist recommended some other biometric devices (rather than Fitbit) and I am concerned that Afib false positives may trigger unneeded concerns on the part of Fitbit users/customers.  Plus, the 30-day ECG I wore billed my insurance $9,000.00!  I have insurance but what if a Fitbit customer was concerned was presecribed the device and DID NOT have insurance!  Would the Fitbit disclaimers avoid any actions against Fitbit (not an attorney, but I would guess yes)?

Just sharing in hopes that upper Fitbit Leadership and developers read this and work to make significant improvements in future products.  I also share this in hopes that others do not recieve false positive readings and have undo distress, physician visits, and costs secondary to Fitbit ECG readings.

Ed Nottingham, PhD

(happily signing my name if anybody at Fitbit ever wants to chat)

[LZeeW]

@EJNIV   I need to start by saying that I'm not a Fitbit employee.  Community Council members are knowledgeable volunteers.  All clinical tests have a false positive and false negative rate.  The clinical study that was done with the ECG app is described in the Fitbit ECG app Physician's Guide.  This guide is readily available in the User Manuals.  The clinical study is described on p 5-7.  The clinical study that was done for the Irregular Rhythm Notifications is described in its instructions for use.  The FDA took the false positive rate into account before approving both features.

I regularly see news articles how the Irregular Rhythm Notifications help users.  Not all people in atrial fibrillation experience obvious symptoms.  There are many instances where a stroke is the initial manifestation of atrial fibrillation.  (Source)  I get the felling that you shared your story because you went through tests that confirmed what you already knew.  I think you are the outlier here.

Again, I want to make clear that I'm not a Fitbit employee.  My background is physiology and biomedical engineering.  I have direct experience with the FDA Device Division.

[EJNIV]

@LZeeW, thanks for your comment.  I appreciate the support, input, and more from this community and the Council members and knowledgeable volunteers.  My main purpose in posting was to encourage developers to consider potential opportunities for continuous improvement.  I am a loyal Fitbit customer dating to the Charge 3.  My desire was also just to share that 30-second ECG "Afib" reading might be false positive, but in any case my strong recommendation would be if such notifications are recieved to consult with their physicians to rule-out Afib or other cardiac issues. 

Ed

[Karmakicker]

I'm probably the minority user in that I don't trust any nonmedical device to be accurate but maybe hint at something to be checked by a doctor.  I do check my BP readings against my BP monitor and it is usually on the money.  But hopefully anyone who gets your type readings would be alarmed enough to see a cardiologist and then accept what they say.  I have a friend with Afib and she has suffered a lot with it...had two ablations so far.  So I see how that would be upsetting.

[LZeeW]

@EJNIV   The developers don't read comments on the device and lifestyle forums.  This is the Charge 5 device forum, a moderated user-to-user help forum.  They read the Feature Suggestion forum.  Any improvements you want to suggest are best done in the Feature Suggestion forum.